FDA Product Code
FDA Product Code QME — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2785
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | 2026-06-18 | Traditional | PDF ↗ |
| K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | 2026-06-11 | Traditional | PDF ↗ |
| K260066 | PanopticAI Vital Signs (1.6.1-22) | PanopticAI Technologies Limited | 2026-05-21 | Traditional | PDF ↗ |
| K251200 | Vital Signs | Oxehealth Limited | 2026-02-02 | Traditional | PDF ↗ |
| K243687 | Vital Signs | Oxehealth Limited | 2025-08-27 | Traditional | PDF ↗ |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | Mindset Medical, Inc. | 2025-05-30 | Traditional | PDF ↗ |
| K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | 2024-12-23 | Traditional | PDF ↗ |
| K241633 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | 2024-11-18 | Traditional | PDF ↗ |
| K232804 | FibriCheck | Qompium NV | 2024-06-07 | Traditional | PDF ↗ |
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | 2023-09-01 | Traditional | PDF ↗ |
| K220899 | Oxehealth Vital Signs | Oxehealth Limited | 2022-04-29 | Special | PDF ↗ |
| K211906 | Vital Signs | Oxehealth Limited | 2021-07-20 | Special | PDF ↗ |
| DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021-03-26 | Direct | — |
Product code QME · Class II · Cardiovascular. Data: openFDA.