FDA 510(k) Application Details - K152809

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K152809
Device Name	Incubator, Neonatal
Applicant	OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. 8880 GORMAN ROAD LAUREL, MD 20723 US Other 510(k) Applications for this Company
Contact	KENNY BELLO 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	09/28/2015
Decision Date	12/31/2015
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