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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