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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K942781
Device Name DIGITAL HOLTER RECORDER
Applicant
Agilent Technologies
20 N.Aviador St.
Camarillo,  CA  95010
Applicant Contact J. DUDLEY HARRIS
Correspondent
Agilent Technologies
20 N.Aviador St.
Camarillo,  CA  95010
Correspondent Contact J. DUDLEY HARRIS
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/13/1994
Decision Date 01/24/1995
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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