FDA 510(k) Application Details - K061071

Device Classification Name	Incubator, Neonatal Transport   More FDA Info for this Device
510(K) Number	K061071
Device Name	Incubator, Neonatal Transport
Applicant	ATOM MEDICAL INC 35 COMMERCE DRIVE IVYLAND, PA 18974 US Other 510(k) Applications for this Company
Contact	MARY STANIEWICZ Other 510(k) Applications for this Contact
Regulation Number	880.5410   More FDA Info for this Regulation Number
Classification Product Code	FPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2006
Decision Date	08/29/2006
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