CAR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Monitor, Spinal-Fluid Pressure, Electrically Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2460
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1993: 1 · 1997: 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 |
|---|---|---|
| EPISENSOR PLUS (K920740) | Industrias Palex C/O Dma Med-Chem Corp. | 1994-03-07 |
| BION MUMPS-G ANTIBODY TEST SYSTEM (K926066) | Bion Ent., Ltd. | 1993-06-15 |
| IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE (K915577) | Impra, Inc. | 1992-03-11 |
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Every clearance here is in the API, with alerts when new ones post.