Oxehealth Vital Signs

Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate

Oxehealth Limited

The following data is part of a premarket notification filed by Oxehealth Limited with the FDA for Oxehealth Vital Signs.

Pre-market Notification Details

Device IDK220899
510k NumberK220899
Device Name:Oxehealth Vital Signs
ClassificationSoftware 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
ContactIain Charlton
CorrespondentIain Charlton
Oxehealth Limited Magdalen Centre North, The Oxford Science Park Oxford,  GB Ox4 4ga
Product CodeQME  
CFR Regulation Number870.2785 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-04-29

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