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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, Programmable
510(k) Number K952164
FOIA Releasable 510(k) K952164
Device Name EMI MODEL FFF-IA
Applicant
New York Heart Instruments, Inc.
C/O Bass & Ullman, Counsel Law
747 Third Ave.
New York,  NY  10017
Applicant Contact IRVING L WIESEN
Correspondent
New York Heart Instruments, Inc.
C/O Bass & Ullman, Counsel Law
747 Third Ave.
New York,  NY  10017
Correspondent Contact IRVING L WIESEN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/03/1995
Decision Date 05/10/1995
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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