The following data is part of a premarket notification filed by Unipower Corp. with the FDA for Unipower Rechargeable Battery Pack.
Device ID | K940842 |
510k Number | K940842 |
Device Name: | UNIPOWER 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 | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-23 |
Decision Date | 1994-09-07 |