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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K932823
Device Name BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK
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 Number870.1130
Classification Product Code
DXN  
Date Received06/09/1993
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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