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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 K940842
Device Name UNIPOWER 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  
Date Received02/23/1994
Decision Date 09/07/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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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