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FDA 510(k) Applications for Medical Device Product Code "QME"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K223622
FaceHeart Corp.
FaceHeart Vitals Software Development Kit (FH vitals SDK)
09/01/2023
DEN200019
Oxehealth Limited
Oxehealth Vital Signs
03/26/2021
K220899
Oxehealth Limited
Oxehealth Vital Signs
04/29/2022
K211906
Oxehealth Limited
Vital Signs
07/20/2021
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