FDA 510(k) Application Details - K193411

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K193411
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	Perma Pure LLC 1001 New Hampshire Ave Lakewood, NJ 08701 US Other 510(k) Applications for this Company
Contact	Sidra Hankins 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	12/09/2019
Decision Date	11/12/2020
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