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FDA 510(k) Application Details - K101024
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K101024
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
SUZUKEN CO., LTD.
1201 RICHARDSON
SUITE 280
RICHARDSON, TX 75080 US
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Contact
LINDA MORGAN
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2010
Decision Date
01/06/2011
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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