510(k) K072119

AIRLIFE NEBULIZER CAP by Cardinalhealth — Product Code CAF

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