510(k) K223622
- Device
- FaceHeart Vitals Software Development Kit (FH vitals SDK)
- Applicant
- Faceheart Corp.
- 510(k) number
- K223622
- Product code
- QME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-01
- Date received
- 2022-12-05
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Morris Chung
- Address
- P.O. Box 309, Ugland House Grand Cayman KY KY1-1104 KY1-1104
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 |
| K220899 | Oxehealth Vital Signs | Oxehealth Limited | 2022-04-29 |
| K211906 | Vital Signs | Oxehealth Limited | 2021-07-20 |
| DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021-03-26 |