FDA 510(k) Application Details - K211800

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K211800
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	Quality in Flow Ltd. 11 HaÆavoda st. Rosh HaÆayin 4801761 IL Other 510(k) Applications for this Company
Contact	Omer Pechter Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2021
Decision Date	12/08/2022
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