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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K002004
Device Name ZYBIT
Applicant
ZYMED MEDICAL INSTRUMENTATION
1201 B NORTH RICE AVE.
OXNARD,  CA  93030
Applicant Contact GRETEL LUMLEY
Correspondent
ZYMED MEDICAL INSTRUMENTATION
1201 B NORTH RICE AVE.
OXNARD,  CA  93030
Correspondent Contact GRETEL LUMLEY
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/03/2000
Decision Date 09/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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