The following data is part of a premarket notification filed by National Custom Ent., Inc. with the FDA for Powrpak Replacement Batteries For Phisio-control Lifepak 5/10.
| Device ID | K934067 |
| 510k Number | K934067 |
| Device Name: | POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 |
| Classification | Dc-defibrillator, High Energy, (including Paddles) |
| Applicant | NATIONAL CUSTOM ENT., INC. 400 GATEWAY BLVD. Burnsville, MN 55337 -2559 |
| Contact | Mike Benyo |
| Correspondent | Mike Benyo NATIONAL CUSTOM ENT., INC. 400 GATEWAY BLVD. Burnsville, MN 55337 -2559 |
| Product Code | DRK |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1993-10-07 |