BZN
8 FDA 510(k) clearances · Product code
102 daysmedian time to decision
206 days90th percentile
8clearances measured
FDA profile
- Official device name
- Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6175
- Medical specialty
- Anesthesiology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2005: 1 · 2006: 5 · 2008: 4 · 2009: 4 · 2017: 10 · 2022: 29
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 |
|---|---|---|
| ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (K924373) | Instrumed, Inc. | 1992-11-25 |
| CART, EMERGENCY, CARDIOPULMONARY (K872558) | Nico Metal Products Corp. | 1987-07-24 |
| MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (K850761) | Medicor USA , Ltd. | 1985-09-19 |
| SERVO CART 170 (K840264) | Siemens Elema AB | 1984-02-04 |
| RMP INTUBATION EQUIP. STORAGE TRAY (K832697) | Rmp Co. | 1983-12-27 |
| PORTABLE OPERAT. RM. MONITORS HS30/40 (K832356) | Medtel Pty. , Ltd. | 1983-10-28 |
| CRASH CART (K832355) | Quinton, Inc. | 1983-10-28 |
| EMERGENCY CART (K772320) | Physio-Control Corp. | 1978-01-03 |
Track BZN automatically
Every clearance here is in the API, with alerts when new ones post.