510(k) K153748

AirLife Misty Finity Nebulizer by Care Fusion — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2017
Date Received
December 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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