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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 K955015
Device Name ZYMED HOLTER SCANNER MODEL 2010
Applicant
Zymed Medical Instrumentation
20 N. Aviador St.
Camarillo,  CA  93010
Applicant Contact JOHN DUDLEY HARRIS
Correspondent
Zymed Medical Instrumentation
20 N. Aviador St.
Camarillo,  CA  93010
Correspondent Contact JOHN DUDLEY HARRIS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/01/1995
Decision Date 03/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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