NONAGON LTD

Address:1 HaEshel Street,Caesarea,IL

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Otoscope (ERA) (3) Oximeter (DQA) (3) Stethoscope, Electronic (DQD) (3) Thermometer, Electronic, Clinical (FLL) (3) Specula Accessories (FXG) (1)

Premarket Exempt

No Yes

Clear

Nonagon - 07290018446102 Catalog Number : MHD-100-02-001

Device Description : The Nonagon N9 device is a home use device. The device is comprised of a handhel The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user’s examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data. The N9 device measure, record, and transmit data of auscultation sound of human body (lung, hear, abdomen), temperature, oxygen saturation (SpO2) and pulse rate, and can be used to send images of an examined body part. In addition, the device includes otoscope where images of the ear can be transmitted to the healthcare provider.

Device Class :

Duns Number: 532283903

Premarket Exempt : No

Product Code : DQA, DQD, ERA, FLL

Prescription Use : Yes

Device Count : 1

Nonagon N9+ - 17290018446154 Catalog Number :

Device Class : 1

Duns Number: 532283903

Premarket Exempt : No

Product Code : DQD, DQA, ERA, FLL

Prescription Use : No

Device Count : 1

N9 speculum - 27290018446120 Catalog Number : MHD-100-02-033

Device Description : ENT ear speculum for Nonagon N9 device

Device Class : 1

Duns Number: 532283903

Premarket Exempt : Yes

Product Code : FXG

Prescription Use : Yes

Device Count : 27

Nonagon N9+ SmartExam - 27290018446151 Catalog Number :

Device Class : 1

Duns Number: 532283903

Premarket Exempt : No

Product Code : DQA, DQD, ERA, FLL

Prescription Use : No

Device Count : 1

Previous 1 Next