510(k) K900854

JOHN BUNN: MEDIX COMPACT TRAVELLER by The John Bunn Co. — Product Code BTT

K900854 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "JOHN BUNN: MEDIX COMPACT TRAVELLER". The FDA issued a decision of Substantially Equivalent on April 23, 1990. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1990
Date Received
February 22, 1990
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