The following data is part of a premarket notification filed by Unipower Corp. with the FDA for Unipowerr Rechargeable Battery Pack.
| Device ID | K935111 |
| 510k Number | K935111 |
| Device Name: | UNIPOWERR RECHARGEABLE BATTERY PACK |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | UNIPOWER CORP. 1216 W. 96TH ST. Minneapolis, MN 55431 |
| Contact | L E Pertl |
| Correspondent | L E Pertl UNIPOWER CORP. 1216 W. 96TH ST. Minneapolis, MN 55431 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-25 |
| Decision Date | 1994-03-28 |