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FDA 510(k) Application Details - K992197
Device Classification Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
More FDA Info for this Device
510(K) Number
K992197
Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant
ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO, CA 93010 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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More FDA Info for this Product Code
Date Received
06/30/1999
Decision Date
07/28/1999
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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