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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 K934015
Device Name RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB
Applicant
Portable Power Systems, Inc.
10336 S. Dransfeldt Rd.
Parker,  CO  80134
Applicant Contact NORMAN A PREMO
Correspondent
Portable Power Systems, Inc.
10336 S. Dransfeldt Rd.
Parker,  CO  80134
Correspondent Contact NORMAN A PREMO
Regulation Number870.5300
Classification Product Code
LDD  
Date Received08/17/1993
Decision Date 02/17/1994
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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