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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
K241633
Mindset Medical, Inc.
Informed Vital Core Application (IVC App)
11/18/2024
K250078
Mindset Medical, Inc.
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
05/30/2025
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
K240890
PanopticAI Technologies Limited
PanopticAI Vital Signs
12/23/2024
K232804
Qompium nv
FibriCheck
06/07/2024
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