FDA 510(k) Application Details - K161719

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K161719
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	SALTER LABS 2365 CAMINO VIDA ROBLE Carlsbad, CA 92011 US Other 510(k) Applications for this Company
Contact	MARA CALER 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	06/22/2016
Decision Date	09/21/2017
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