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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 K931266
Device Name BATTERY PACK #1012NC
Applicant
Portable Power Systems, Inc.
1940 Tee Ln.
Castle Rock,  CO  80104
Applicant Contact NORMAN PREMO
Correspondent
Portable Power Systems, Inc.
1940 Tee Ln.
Castle Rock,  CO  80104
Correspondent Contact NORMAN PREMO
Regulation Number870.5300
Classification Product Code
LDD  
Date Received03/08/1993
Decision Date 02/03/1994
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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