510(k) K962223

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

K962223 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on January 14, 1997. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.

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