510(k) K220899
- Device
- Oxehealth Vital Signs
- Applicant
- Oxehealth Limited
- 510(k) number
- K220899
- Product code
- QME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-29
- Date received
- 2022-03-28
- Regulation
- 870.2785
- Classification name
- Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Iain Charlton
- Address
- Magdalen Centre N., The Oxford Science Park Oxford GB OX4 4GA OX4 4GA
FDA Registration Numbers#
- 3028169073
- 3015976873
- 3019791389
- 3037699312
- 3017840920
Source Documents#
Other 510(k) Records For Product Code QME #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260066 | PanopticAI Vital Signs (1.6.1-22) | PanopticAI Technologies Limited | 2026-05-21 |
| K251200 | Vital Signs | Oxehealth Limited | 2026-02-02 |
| K243687 | Vital Signs | Oxehealth Limited | 2025-08-27 |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | Mindset Medical, Inc. | 2025-05-30 |
| K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | 2024-12-23 |
| K241633 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | 2024-11-18 |
| K232804 | FibriCheck | Qompium NV | 2024-06-07 |
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | 2023-09-01 |
| K211906 | Vital Signs | Oxehealth Limited | 2021-07-20 |
| DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021-03-26 |
Legacy Summary#
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FDA Review#
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