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510(k) K243687

Vital Signs by Oxehealth Limited — Product Code QME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2025
Date Received
November 29, 2024
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 Oxehealth Limited

  • K251200 — Vital Signs (February 2, 2026)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K220899 — Oxehealth Vital Signs (April 29, 2022)
  • K211906 — Vital Signs (July 20, 2021)
  • DEN200019 — Oxehealth Vital Signs (March 26, 2021)

Other clearances for product code QME

  • K251200 — Vital Signs (February 2, 2026)
  • 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)
  • K223622 — FaceHeart Vitals Software Development Kit (FH vitals SDK) (September 1, 2023)
  • K220899 — Oxehealth Vital Signs (April 29, 2022)
  • K211906 — Vital Signs (July 20, 2021)
  • DEN200019 — Oxehealth Vital Signs (March 26, 2021)