DRK · Dc-Defibrillator, High Energy, (Including Paddles)
Cardiovascular · 21 CFR 870.5300 · Class 3
Overview
| Product Code | DRK |
|---|---|
| Device Name | Dc-Defibrillator, High Energy, (Including Paddles) |
| Regulation | 21 CFR 870.5300 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
Identification
Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.
Classification Rationale
Low-energy DC-defibrillator: Class II (performance standards). High-energy DC-defibrillator: Class III (premarket approval).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934067 | POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 | National Custom Ent., Inc. | Oct 7, 1993 | SESE |
Top Applicants
- National Custom Ent., Inc. — 1 clearance
