FDA 510(k) Application Details - K102710

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K102710
Device Name	Incubator, Neonatal
Applicant	ATOM MEDICAL CORPORATION 24301 WOODSTAGE DRIVE BONITA SPRINGS, FL 34134 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	09/20/2010
Decision Date	12/22/2010
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