FDA 510(k) Application Details - K113542

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K113542
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	SALTER LABS, ARVIN FACILITY 100 Sycamore Rd ARVIN, CA 93203 US Other 510(k) Applications for this Company
Contact	MICHAEL SHOUP 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	12/01/2011
Decision Date	02/10/2012
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	Y
Expedited Review