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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 K930806
Device Name ZYMED HOLTER SCANNER MODEL 2010
Applicant
Agilent Technologies
20 N. Aviador St.
Camarillo,  CA  93010
Applicant Contact JOSE GONZALEZ
Correspondent
Agilent Technologies
20 N. Aviador St.
Camarillo,  CA  93010
Correspondent Contact JOSE GONZALEZ
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/16/1993
Decision Date 04/25/1994
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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