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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 K861992
Device Name MODEL 43200A CARDIAC MONITOR
Applicant
HEWLETT-PACKARD CO.
1700 SOUTH BAKER ST.
MCMINNVILLE,  OR  97128
Applicant Contact RICHARD W STRAYER
Correspondent
HEWLETT-PACKARD CO.
1700 SOUTH BAKER ST.
MCMINNVILLE,  OR  97128
Correspondent Contact RICHARD W STRAYER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/23/1986
Decision Date 06/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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