FDA 510(k) Application Details - K092970

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K092970
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant GENERAL MEDITECH, INC.
SUITE 5D, NO.19, LANE 999
ZHONGSHAN NO. 2 ROAD (S)
SHANGHAI 200030 CN
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Contact LEE FU
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 09/25/2009
Decision Date 02/02/2010
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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