FDA 510(k) Application Details - K953489

Device Classification Name	Warmer, Infant Radiant   More FDA Info for this Device
510(K) Number	K953489
Device Name	Warmer, Infant Radiant
Applicant	DRAGER, INC. 4101-100 PLEASANT VALLEY RD. CHANTILLY, VA 22021 US Other 510(k) Applications for this Company
Contact	HARALD KNEUER Other 510(k) Applications for this Contact
Regulation Number	880.5130   More FDA Info for this Regulation Number
Classification Product Code	FMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/1995
Decision Date	02/09/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review