Cleared Traditional

HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER

K955104 · Automatic Liquid Packaging, Inc. · Anesthesiology
Jun 1996
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K955104 is an FDA 510(k) clearance for the HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on June 11, 1996, 216 days after receiving the submission on November 8, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K955104 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1995
Decision Date June 11, 1996
Days to Decision 216 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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