510(k) K962072

PRONEB TURBO COMPRESSOR MODEL 38V0200 by Pari Holding Co. — Product Code CAF

K962072 is an FDA 510(k) premarket notification submitted by Pari Holding Co. for the device "PRONEB TURBO COMPRESSOR MODEL 38V0200". The FDA issued a decision of Substantially Equivalent on August 21, 1996. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Pari Holding Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1996
Date Received
May 28, 1996
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