FDA 510(k) Application Details - K123937

Device Classification Name	Incubator, Neonatal Transport   More FDA Info for this Device
510(K) Number	K123937
Device Name	Incubator, Neonatal Transport
Applicant	ATOM MEDICAL CORPORATION 24301 WOODSAGE 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	880.5410   More FDA Info for this Regulation Number
Classification Product Code	FPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2012
Decision Date	05/23/2013
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