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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K010949
Device Name 2010 PLUS HOLTER FOR WINDOWS
Applicant
Agilent Technologies
1201 "B" N. Rice Ave.
Oxnard,  CA  93030
Applicant Contact GRETEL LUMLEY
Correspondent
Agilent Technologies
1201 "B" N. Rice Ave.
Oxnard,  CA  93030
Correspondent Contact GRETEL LUMLEY
Regulation Number870.2800
Classification Product Code
MLO  
Date Received03/29/2001
Decision Date 09/28/2001
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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