American Telecare, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What American Telecare, Inc. makes
American Telecare, Inc. manufactures telemedicine devices including a phonetic stethoscope for remote auscultation, personal telemedicine systems and modules for transmitting vital signs and medical data, and the CareTone II for diagnostic monitoring. Their product line also includes the Aviva Systems (models 1010, 2020, SL1010, SL2020, SLX1010) for patient monitoring and the NX System for telehealth applications.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight.
Catalogue
Telphonic Stethoscope Ref K945638
Regimes: 510(k) Registry: 510(k)Personal Telemedicine System Ref K952882
Regimes: 510(k) Registry: 510(k)Personal Telemedicine Module Ref K964554
Regimes: 510(k) Registry: 510(k)Caretone Ii Ref K963678
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Aviva Systems Model Numbers 1010, 2020 Ref K981533
Regimes: 510(k) Registry: 510(k)Aviva System, Model SL1010 Ref K993550
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Nx System Ref K030222
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Telecare, Inc. have in the registry?
The registry currently lists 9 devices for American Telecare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Telecare, Inc.'s devices?
Among its 9 most recently registered devices, American Telecare, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do American Telecare, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for American Telecare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Telecare, Inc. in the registry?
The most recently registered devices listed for American Telecare, Inc. include TELPHONIC STETHOSCOPE, PERSONAL TELEMEDICINE SYSTEM, PERSONAL TELEMEDICINE MODULE and CARETONE II.