Address:215 West 40th St.,New York,NY,10018,US
Device Description : The TytoCare unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It i The TytoCare unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro 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 Basal Thermometer:The Tyto Basal Thermometer is an electronic thermometer that enables measuring basalbody temperature as an aid in ovulation prediction to aid in conception (not to be usedfor contraception). In addition, the thermometer enables storage and transmitting thetemperature measurement to a clinician on site or at a different location on the IP networkwith the signal carried on an IP connection between the 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 ofau The Tyto Stethoscope is an electronic stethoscope that enables transmission ofauscultation sound data, whereby a clinician at one location on an IP network can listen tothe auscultation sounds of a patient on site or at a different location on the IP network withthe signal carried on an IP connection between the two locations. The Tyto stethoscopeis intended for use by professional users in a clinical environment or in conjunction withpatients or lay users in a non-clinical environment.
Device Class :
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : Yes
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 :
Duns Number: 649125325
Premarket Exempt : Yes
Prescription Use : No
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 basal thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope.TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672036.
Device Class :
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : Yes
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, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672050.
Device Class :
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Tyto Device unit contains the Tyto Exam Camera and Tyto Basal Thermometer. I The Tyto Device unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro 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 Basal Thermometer:The Tyto Basal Thermometer is an electronic thermometer that enables measuring basalbody temperature as an aid in ovulation prediction to aid in conception (not to be usedfor contraception). In addition, the thermometer enables storage and transmitting thetemperature measurement to a clinician on site or at a different location on the IP networkwith the signal carried on an IP connection between the 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
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, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672183 Tyto Device with Basal Thermometer and Exam Camera, 07290016672190 Tyto Stethoscope and 07290016672206 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with 17290016672210.
Device Class : 1
Duns Number: 649125325
Premarket Exempt : No
Prescription Use : No