510(k) K955104

HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER by Automatic Liquid Packaging, Inc. — Product Code CAF

K955104 is an FDA 510(k) premarket notification submitted by Automatic Liquid Packaging, Inc. for the device "HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER". The FDA issued a decision of Substantially Equivalent on June 11, 1996. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Automatic Liquid Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1996
Date Received
November 8, 1995
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