Hemo Sapiens, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Hemo Sapiens, Inc. makes
Hemo Sapiens, Inc. manufactures the TEBCO device, a thoracic electrical bioimpedance system used for measuring cardiac output, and the HOTMAN device, which appears to be a related or complementary cardiac monitoring tool.
These products fall under Class II regulatory classification and are authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Hotman Ref K952172
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hemo Sapiens, Inc. have in the registry?
The registry currently lists 2 devices for Hemo Sapiens, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemo Sapiens, Inc.'s devices?
Among its 2 most recently registered devices, Hemo Sapiens, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hemo Sapiens, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hemo Sapiens, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hemo Sapiens, Inc. in the registry?
The most recently registered devices listed for Hemo Sapiens, Inc. include TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) and HOTMAN.