Femtek, LLC.
United StatesFDA applicant, unverified
- Devices
- 3
What Femtek, LLC. makes
Femtek, LLC manufactures point-of-care diagnostic devices for detecting and monitoring physiological conditions, including the PHEM-ALERT and PHEM-CHEK systems. These tools are designed to provide real-time alerts and verification for critical patient parameters, such as perfusion and oxygenation status.
The company’s portfolio is classified under FDA’s Class I regulatory category, with devices listed via the 510(k) clearance process. Products are based in the United States and comply with U.S. medical device regulations.
Catalogue
Phem-Alert Ref K032161
Regimes: 510(k) Registry: 510(k)Phem-Chek Ref K960648
Regimes: 510(k) Registry: 510(k)Phem-Alert Ref K012230
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Femtek, Llc. have in the registry?
The registry currently lists 3 devices for Femtek, Llc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Femtek, Llc.'s devices?
Among its 3 most recently registered devices, Femtek, Llc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Femtek, Llc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Femtek, Llc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Femtek, Llc. in the registry?
The most recently registered devices listed for Femtek, Llc. include PHEM-ALERT and PHEM-CHEK.