Cardionics, Inc.
United StatesFDA applicant, unverified
Cardionics, Inc. is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 14 Nov 2026.
- Devices
- 4
Registry facts
- Registries
- FDA 510(k) 2
- FDA GUDID 2
- Device classes
- FDA Class II 4
- Identifiers
- DUNS 018076950
What Cardionics, Inc. makes
Cardionics, Inc. manufactures electronic acoustic stethoscopes, including models such as the E-Scope Hearing Impaired, E-Scope, CARTOUCH, and SPECTRUM POLYCORD I RECORDER SYSTEM.
The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Cartouch Ref K002197
Regimes: 510(k) Registry: 510(k)Spectrum Polycord I Recorder System Ref K862776
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 018076950
Frequently asked questions
How many devices does Cardionics, Inc. have in the registry?
The registry currently lists 4 devices for Cardionics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardionics, Inc.'s devices?
Among its 4 most recently registered devices, Cardionics, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cardionics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Cardionics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardionics, Inc. in the registry?
The most recently registered devices listed for Cardionics, Inc. include E-Scope Hearing Impaired 7187710, E-Scope 7187700, CARTOUCH and SPECTRUM POLYCORD I RECORDER SYSTEM.