Device Classification Name |
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
|
510(k) Number |
K220899 |
Device Name |
Oxehealth Vital Signs |
Applicant |
Oxehealth Limited |
Magdalen Centre North, The Oxford Science Park |
Oxford,
GB
OX4 4GA
|
|
Applicant Contact |
Iain Charlton |
Correspondent |
Oxehealth Limited |
Magdalen Centre North, The Oxford Science Park |
Oxford,
GB
OX4 4GA
|
|
Correspondent Contact |
Iain Charlton |
Regulation Number | 870.2785
|
Classification Product Code |
|
Date Received | 03/28/2022 |
Decision Date | 04/29/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|