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FDA 510(k) Application Details - K063339
Device Classification Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
More FDA Info for this Device
510(K) Number
K063339
Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant
MEDICK HEALTHCARE LTD.
8303 N.E. JUANITA DRIVE
KIRKLAND, WA 98034 US
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Contact
JAMES W SANDBERG
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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
11/06/2006
Decision Date
06/29/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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