FDA 510(k) Application Details - K162821

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K162821
Device Name	Incubator, Neonatal
Applicant	Draegerwerk AG & Co. KGaA Moislinger Allee 53-55 Luebeck 23542 DE Other 510(k) Applications for this Company
Contact	Bettina Moebius 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	10/07/2016
Decision Date	06/23/2017
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