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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 K861092
Device Name MODEL SP1465 CARDIAC OUTPUT COMPUTER
Applicant
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ROBERT L LEAVITT
Correspondent
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ROBERT L LEAVITT
Regulation Number870.1435
Classification Product Code
DXG  
Date Received03/24/1986
Decision Date 08/18/1986
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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