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FDA 510(k) Application Details - K112573
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K112573
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
PLATINUM TEAM CO., LTD
396 DAYE ROAD
TAIPAI 11268 TW
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Contact
JAMES HO
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
MWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2011
Decision Date
03/22/2012
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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