Product code MPE— Cardiovascular
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
- Classification name
- Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code MPE
FDA has cleared device under product code MPE, all in 1995, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code MPE
Recent clearances under product code MPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.