FOA
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Board, Cardiopulmonary
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6080
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1998: 3 · 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EleGARD (K221901) | Advancedcpr Solutions, LLC | 2022-07-29 |
| EleGARD Patient Positioning System (K191689) | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | 2020-02-13 |
| ECA (K811397) | Gillco, Inc. | 1981-07-02 |
Track FOA automatically
Every clearance here is in the API, with alerts when new ones post.