Device Type ID | 886 |
Device Name | Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator |
Regulation Description | DC-defibrillator (including Paddles). |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
Submission Type | 510(k) |
CFR Regulation Number | 870.5300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MPD |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | Yes |
Third Party Review | Not Third Party Eligible |
Device Type ID | 886 |
Device | Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator |
Product Code | MPD |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | DC-defibrillator (including Paddles). |
CFR Regulation Number | 870.5300 [🔎] |