FDA 510(k) Application Details - K233707

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K233707
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	Invent Medical Corporation 2788 Loker Ave. W. Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	David Gramse 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	11/20/2023
Decision Date	06/14/2024
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