Healthdyne Cardiovascular, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Healthdyne Cardiovascular, Inc. makes
Healthdyne Cardiovascular, Inc. manufactures intrauterine pressure monitoring systems, including the ISOFLO and ISOTEC devices for real-time fetal monitoring, as well as related accessories such as amniocentesis trays, high-pressure injection lines, and dressing change kits for obstetric procedures.
The company’s portfolio includes Class I and Class II devices, with submissions recorded under the FDA’s 510(k) pathway. These products are listed in the U.S. regulatory registry, adhering to domestic medical device classification standards.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Isoflo(Tm) Amniocentesis Tray Ref K901643
Regimes: 510(k) Registry: 510(k)Dressing Change Kit Ref K900665
Regimes: 510(k) Registry: 510(k)Isoflo(Tm) High Pressure Injection Lines Ref K901382
Regimes: 510(k) Registry: 510(k)Isoflo Intrauterine Pressure Monitoring & Amnio. Ref K901084
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthdyne Cardiovascular, Inc. have in the registry?
The registry currently lists 5 devices for Healthdyne Cardiovascular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthdyne Cardiovascular, Inc.'s devices?
Among its 5 most recently registered devices, Healthdyne Cardiovascular, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Healthdyne Cardiovascular, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Healthdyne Cardiovascular, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthdyne Cardiovascular, Inc. in the registry?
The most recently registered devices listed for Healthdyne Cardiovascular, Inc. include ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING, ISOFLO(TM) AMNIOCENTESIS TRAY, DRESSING CHANGE KIT and ISOFLO(TM) HIGH PRESSURE INJECTION LINES.