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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 K990170
Device Name HOLTER 2000
Applicant
ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Applicant Contact GRETEL LUMLEY
Correspondent
ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Correspondent Contact GRETEL LUMLEY
Regulation Number870.2800
Classification Product Code
MLO  
Date Received01/19/1999
Decision Date 04/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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