Heartlung Corporation
United Statesfrom the FDA registration address FDA establishment FEI 3039211310
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
What Heartlung Corporation makes
Heartlung Corporation manufactures ABMD software, AutoChamber devices, and AI-CVD systems.
These products are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
ABMD Software Ref K213760
Regimes: 510(k) Registry: 510(k)AutoChamber Ref K240786
Regimes: 510(k) Registry: 510(k)Ai-Cvd Ref K252029
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3039211310
- Address
- 2450 Holcombe Blvd, Houston, TX, 77021
Frequently asked questions
How many devices does HEARTLUNG CORPORATION have in the registry?
The registry currently lists 5 devices for HEARTLUNG CORPORATION. Devices recorded under merged duplicate company entries are counted once.
Which registries list HEARTLUNG CORPORATION's devices?
Among its 5 most recently registered devices, HEARTLUNG CORPORATION has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do HEARTLUNG CORPORATION's devices fall under?
Among its 5 most recently registered devices, the classes recorded for HEARTLUNG CORPORATION's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from HEARTLUNG CORPORATION in the registry?
The most recently registered devices listed for HEARTLUNG CORPORATION include AutoBMD V2.2.3, AI-CVD V0.3.0, ABMD Software and AutoChamber.