The following data is part of a premarket notification filed by Oxehealth Limited with the FDA for Oxehealth Vital Signs.
| Device ID | K220899 |
| 510k Number | K220899 |
| Device Name: | Oxehealth Vital Signs |
| Classification | Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate |
| Applicant | Oxehealth Limited Magdalen Centre North, The Oxford Science Park Oxford, GB Ox4 4ga |
| Contact | Iain Charlton |
| Correspondent | Iain Charlton Oxehealth Limited Magdalen Centre North, The Oxford Science Park Oxford, GB Ox4 4ga |
| Product Code | QME |
| CFR Regulation Number | 870.2785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-04-29 |