FDA 510(k) Application Details - K053399

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K053399
Device Name	Incubator, Neonatal
Applicant	DRAEGER MEDICAL INFANT CARE, INC. 330 JACKSONVILLE RD. HATBORO, PA 19040 US Other 510(k) Applications for this Company
Contact	MONICA FERRANTE 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	12/06/2005
Decision Date	08/04/2006
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