FDA 510(k) Application Details - K222351

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K222351
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	Vincent Healthcare Products Limited Flat/RM B2, 7/F., Hang Fung Industrial Building, Phase 2, 2G Hok Yuen Street Hung Hom HK Other 510(k) Applications for this Company
Contact	Patrick Dennis 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	08/04/2022
Decision Date	12/21/2022
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