FDA 510(k) Application Details - K110374

Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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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
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Regulation Number 870.2780

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Classification Product Code JOM
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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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