MPE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5550
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2005: 2 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR (K945511) | Physio-Control Corp. | 1995-09-26 | + Add |
Track MPE automatically
Every clearance here is in the API, with alerts when new ones post.