510(k) K962223

WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER by Marquest Medical Products, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1997
Date Received
June 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type