FDA 510(k) Application Details - K132543

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K132543
Device Name	Incubator, Neonatal
Applicant	BISTOS CO., LTD. 27 NEW ENGLAND DRIVE RAMSEY, NJ 07446 US Other 510(k) Applications for this Company
Contact	YOUNG CHI Other 510(k) Applications for this Contact
Regulation Number	880.5400   More FDA Info for this Regulation Number
Classification Product Code	FMZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2013
Decision Date	07/03/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review