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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K843555
Device Name CARDIAC COMPUTER SP1445
Applicant
GOULD, INC.
1900 WILLIAMS DR.
OXNARD,  CA  93030
Applicant Contact ARCHER S GORDON
Correspondent
GOULD, INC.
1900 WILLIAMS DR.
OXNARD,  CA  93030
Correspondent Contact ARCHER S GORDON
Regulation Number870.1435
Classification Product Code
DXG  
Date Received09/10/1984
Decision Date 02/01/1985
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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