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FDA 510(k) Application Details - K110374
Device Classification Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
More FDA Info for this Device
510(K) Number
K110374
Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant
MEDICORE CO., LTD.
3F, SAMWOO B/D, 339-2, JAMSIL
DONG, SONGPA-GU
SEOUL KR
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Contact
YOO BYUNG-KUK
Other 510(k) Applications for this Contact
Regulation Number
870.2780
More FDA Info for this Regulation Number
Classification Product Code
JOM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/09/2011
Decision Date
06/13/2011
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
Y
Expedited Review
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