FDA 510(k) Application Details - K213553

Device Classification Name	Incubator, Neonatal   More FDA Info for this Device
510(K) Number	K213553
Device Name	Incubator, Neonatal
Applicant	Datex Ohmeda Inc. 9900 Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Shiwani Zalpuri 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	11/08/2021
Decision Date	03/02/2022
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