FDA 510(k) Application Details - K971260

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K971260
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	RESMED CORP. 5744 PACIFIC CENTER BLVD., SUITE 311 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	MICHAEL HALLETT 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	04/04/1997
Decision Date	09/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review