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510(k) DEN200019

Oxehealth Vital Signs by Oxehealth Limited — Product Code QME

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 26, 2021
Date Received
March 27, 2020
Clearance Type
Direct
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)
  • K243687 — Vital Signs (August 27, 2025)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K220899 — Oxehealth Vital Signs (April 29, 2022)
  • K211906 — Vital Signs (July 20, 2021)

Other clearances for product code QME

  • K251200 — Vital Signs (February 2, 2026)
  • 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)
  • 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)