FDA 510(k) Application Details - K182859

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K182859
Device Name	Incubator, Neonatal
Applicant	Dragerwerk AG & Co. KGaA Moislinger Allee 53-55 Lubeck 23542 DE Other 510(k) Applications for this Company
Contact	Dr. Bettina Mobius 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	10/11/2018
Decision Date	02/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review