FDA 510(k) Application Details - K222822

Device Classification Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer   More FDA Info for this Device
510(K) Number	K222822
Device Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant	Draegerwerk AG & Co. KGaA Moislinger Allee 53-55 Luebeck 23542 DE Other 510(k) Applications for this Company
Contact	Jan Upmeier Other 510(k) Applications for this Contact
Regulation Number	868.5270   More FDA Info for this Regulation Number
Classification Product Code	BZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2022
Decision Date	06/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review