FDA 510(k) Application Details - K003763

Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm

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510(K) Number K003763
Device Name Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant AGILENT TECHNOLOGIES
1201 "B" N. RICE AVE.
OXNARD, CA 93030 US
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Contact GRETEL LUMLEY
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Regulation Number 870.2800

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Classification Product Code MLO
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Date Received 12/06/2000
Decision Date 01/05/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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