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FDA 510(k) Application Details - K110922
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K110922
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
EDAN INSTRUMENTS, INC.
3/F-B, NANSHAN MEDICAL
EQUIPMENTS PARK, NANHAI RD1019
SHENZHEN, GUANGDONG 518067 CN
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Contact
RANDY JIANG
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
MHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2011
Decision Date
07/20/2011
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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