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510(k) K223622

FaceHeart Vitals Software Development Kit (FH vitals SDK) by Faceheart Corp. — Product Code QME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2023
Date Received
December 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Device Class
Class II
Regulation Number
870.2785
Review Panel
CV
Submission Type

The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.

Other clearances by Faceheart Corp.

  • K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (April 9, 2025)

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  • K243687 — Vital Signs (August 27, 2025)
  • K250078 — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (May 30, 2025)
  • K240890 — PanopticAI Vital Signs (December 23, 2024)
  • K241633 — Informed Vital Core Application (IVC App) (November 18, 2024)
  • K232804 — FibriCheck (June 7, 2024)
  • K220899 — Oxehealth Vital Signs (April 29, 2022)
  • K211906 — Vital Signs (July 20, 2021)
  • DEN200019 — Oxehealth Vital Signs (March 26, 2021)