Address:215 West 40th St.,New York,NY,10018,US
Device Description : Designed for professional use, TytoPro used for comprehensive remote exam and te Designed for professional use, TytoPro used for comprehensive remote exam and telehealth.TytoCare device with high resolution video and still camera, no-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672367 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope.TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672296 and 54 pack logistic carton labeled with 27290016672293.
Device Class :
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No
Device Description : TytoHome used for comprehensive remote exam and telehealth.TytoCare device with TytoHome used for comprehensive remote exam and telehealth.TytoCare device with high resolution video and still camera, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672302.
Device Class : 1
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No
Device Description : The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoHome kit components: the Tyto Stethoscope and Tyto OttoscopeIntended use for Tyto Exam Camera:The Tyto Camera is an electronic camera that enables capturing and transmission of videoand still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at onelocation on an IP network can view images and videos of a patient on site or at a differentlocation on the IP network with the signal carried on an IP connection between the twolocations.Intended use for Tyto Thermometer:The Tyto Thermometer is a clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead as the measurement site on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments
Device Class : 1
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No
Device Description : The Tyto Stethoscope is an electronic stethoscope that enables transmission of a The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Device Class : 2
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No
Device Description : The Tyto Otoscope is an electronic otoscope that enables capturing and transmiss The Tyto Otoscope is an electronic otoscope that enables capturing and transmissionof video and still images of the external ear canal and tympanic membrane, whereby aclinician at one location on an IP network can view images and videos of a patient on site orat a different location on the IP network with the signal carried on an IP connection betweenthe two locations.
Device Class : 1
Duns Number: 649125325
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto OtoscopeIntended use for Tyto Exam Camera:The Tyto Camera is an electronic camera that enables capturing and transmission of videoand still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at onelocation on an IP network can view images and videos of a patient on site or at a differentlocation on the IP network with the signal carried on an IP connection between the twolocations.Intended use for Tyto Thermometer:The Tyto Thermometer is a clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead as the measurement site on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments
Device Class : 1
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No
Device Description : The Tyto Stethoscope is an electronic stethoscope that enables transmission of a The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Device Class : 2
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No
Device Description : The Tyto Otoscope is an electronic otoscope that enables capturing and transmiss The Tyto Otoscope is an electronic otoscope that enables capturing and transmissionof video and still images of the external ear canal and tympanic membrane, whereby aclinician at one location on an IP network can view images and videos of a patient on site orat a different location on the IP network with the signal carried on an IP connection betweenthe two locations.
Device Class : 1
Duns Number: 649125325
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Tyto Stethoscope is an electronic stethoscope that enables transmission of a The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Device Class : 2
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No
Device Description : The Tyto Otoscope is an electronic otoscope that enables capturing and transmiss The Tyto Otoscope is an electronic otoscope that enables capturing and transmissionof video and still images of the external ear canal and tympanic membrane, whereby aclinician at one location on an IP network can view images and videos of a patient on site orat a different location on the IP network with the signal carried on an IP connection betweenthe two locations.
Device Class : 1
Duns Number: 649125325
Premarket Exempt : Yes
Prescription Use : No