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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K935111
Device Name UNIPOWERR RECHARGEABLE BATTERY PACK
Applicant
Unipower Corp.
1216 W. 96th St.
Minneapolis,  MN  55431
Applicant Contact L E PERTL
Correspondent
Unipower Corp.
1216 W. 96th St.
Minneapolis,  MN  55431
Correspondent Contact L E PERTL
Regulation Number870.5300
Classification Product Code
LDD  
Subsequent Product Code
DRK  
Date Received10/25/1993
Decision Date 03/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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