FDA 510(k) Application Details - K231380

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K231380
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045 US Other 510(k) Applications for this Company
Contact	Megan Walsh Other 510(k) Applications for this Contact
Regulation Number	868.5450   More FDA Info for this Regulation Number
Classification Product Code	BTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2023
Decision Date	08/10/2023
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