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FDA 510(k) Application Details - K161302
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K161302
Device Name
Electrocardiograph
Applicant
EDAN INSTRUMENTS, INC.
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD 1019#
SHENZHEN 518067 CN
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Contact
ERICO LI
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2016
Decision Date
07/01/2016
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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