510(k) K072119

AIRLIFE NEBULIZER CAP by Cardinalhealth — Product Code CAF

K072119 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "AIRLIFE NEBULIZER CAP". The FDA issued a decision of Substantially Equivalent on August 10, 2007. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Cardinalhealth has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2007
Date Received
August 1, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type