QME — Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate Class II
Classification Details
- Product Code
- QME
- Device Class
- Class II
- Regulation Number
- 870.2785
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251200 | oxehealth limited | Vital Signs | February 2, 2026 |
| K243687 | oxehealth limited | Vital Signs | August 27, 2025 |
| K250078 | mindset medical | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | May 30, 2025 |
| K240890 | panopticai technologies limited | PanopticAI Vital Signs | December 23, 2024 |
| K241633 | mindset medical | Informed Vital Core Application (IVC App) | November 18, 2024 |
| K232804 | qompium | FibriCheck | June 7, 2024 |
| K223622 | faceheart | FaceHeart Vitals Software Development Kit (FH vitals SDK) | September 1, 2023 |
| K220899 | oxehealth limited | Oxehealth Vital Signs | April 29, 2022 |
| K211906 | oxehealth limited | Vital Signs | July 20, 2021 |
| DEN200019 | oxehealth limited | Oxehealth Vital Signs | March 26, 2021 |