FDA 510(k) Application Details - K021809

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K021809
Device Name	Incubator, Neonatal
Applicant	ATOM MEDICAL CORP. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	SHEILA HEMEON-HEYER 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	06/03/2002
Decision Date	07/18/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review