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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 K861505
Device Name HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
Applicant
American Medical Equipment, Inc.
71 Fifth Ave.
New York,  NY  10003
Applicant Contact ZIPORAH RUBINSTEIN
Correspondent
American Medical Equipment, Inc.
71 Fifth Ave.
New York,  NY  10003
Correspondent Contact ZIPORAH RUBINSTEIN
Regulation Number870.1435
Classification Product Code
DXG  
Date Received04/23/1986
Decision Date 04/10/1987
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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