FDA 510(k) Application Details - K103523

Device Classification Name	Incubator, Neonatal Transport   More FDA Info for this Device
510(K) Number	K103523
Device Name	Incubator, Neonatal Transport
Applicant	INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. AUSTIN, TX 78754 US Other 510(k) Applications for this Company
Contact	AMY PIEPER 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	12/01/2010
Decision Date	05/11/2011
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