FDA 510(k) Application Details - K972885

Device Classification Name	Warmer, Infant Radiant   More FDA Info for this Device
510(K) Number	K972885
Device Name	Warmer, Infant Radiant
Applicant	FISHER & PAYKEL ELECTRONICS LTD. HEALTHCARE DIV. 25 CARBINE RD., P.O. BOX 14348 AUCKLAND NZ Other 510(k) Applications for this Company
Contact	CHRIS MANDER 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	08/05/1997
Decision Date	10/30/1997
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