510(k) K944152

PARI BABY by Pari Holding Co. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1994
Date Received
August 22, 1994
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