Medical Device Manufacturer · KY , Grand Cayman

Faceheart Corp.

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied

Faceheart Corp. — FDA 510(k) Submissions

Faceheart Corp. has submitted 2 FDA 510(k) premarket notifications since 2023, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate, Monitor, Breathing Frequency . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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