MPE — Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker Class II
FDA product code MPE covers "Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker", a Class II medical device regulated under 21 CFR 870.5550. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- MPE
- Device Class
- Class II
- Regulation Number
- 870.5550
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K945511 | physio-control | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | September 26, 1995 |