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 |