Softheart, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Softheart, Inc. makes
Softheart, Inc. manufactures systems for analyzing and recording physiological data, including off-line and on-line analysis systems designed for medical monitoring. Their CATHWRITER™ device is specifically used for recording intracardiac electrograms during cardiac procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Off-Line Analysis System Ref K921216
Regimes: 510(k) Registry: 510(k)On-Line Analysis System Ref K930639
Regimes: 510(k) Registry: 510(k)Cathwriter(Tm) Ref K914105
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Softheart, Inc. have in the registry?
The registry currently lists 3 devices for Softheart, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Softheart, Inc.'s devices?
Among its 3 most recently registered devices, Softheart, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Softheart, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Softheart, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Softheart, Inc. in the registry?
The most recently registered devices listed for Softheart, Inc. include OFF-LINE ANALYSIS SYSTEM, ON-LINE ANALYSIS SYSTEM and CATHWRITER(TM).