FDA 510(k) Application Details - K223551

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K223551
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	Hometa Inc 300 Great Oaks Blvd, Suite 325 Albany, NY 12203 US Other 510(k) Applications for this Company
Contact	Raza Mohammed 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	11/25/2022
Decision Date	08/03/2023
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