FDA 510(k) Application Details - K974349

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K974349
Device Name	Incubator, Neonatal
Applicant	OHMEDA MEDICAL 9065 GUILFORD RD. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	ALBERTO F PROFUMO 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	11/19/1997
Decision Date	02/12/1998
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