Signalife, Inc.
Country not established
- Devices
- 1
What Signalife, Inc. makes
Signalife, Inc. manufactures the FIDELITY 200, a cardiac event recorder designed to remotely capture and transmit electrocardiogram (ECG) data for diagnostic evaluation of intermittent cardiac symptoms.
The company’s devices are classified under Class II by the FDA and are listed via the 510(k) pathway. Signalife, Inc. is based in the United States.
Catalogue
Fidelity 200 Cardiac Event Recorder Ref K071228
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Signalife, Inc. have in the registry?
The registry currently lists 1 device for Signalife, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Signalife, Inc.'s devices?
Among its 1 most recently registered device, Signalife, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Signalife, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Signalife, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Signalife, Inc. in the registry?
The most recently registered devices listed for Signalife, Inc. include FIDELITY 200 CARDIAC EVENT RECORDER.