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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K934439
Device Name RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR
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 Number870.2340
Classification Product Code
DPS  
Date Received08/23/1993
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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