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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K910291
Device Name MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
Applicant
HEWLETT-PACKARD CO.
1700 SOUTH BAKER ST.
MCMINNVILLE,  OR  97128
Applicant Contact MONICA FERRANTE
Correspondent
HEWLETT-PACKARD CO.
1700 SOUTH BAKER ST.
MCMINNVILLE,  OR  97128
Correspondent Contact MONICA FERRANTE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received01/23/1991
Decision Date 04/22/1991
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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