Cleared Traditional

ADJUSTABLE ENTRAINMENT NEBULIZER

K882936 · Automatic Liquid Packaging, Inc. · Anesthesiology
Jan 1989
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K882936 is an FDA 510(k) clearance for the 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 January 9, 1989, 180 days after receiving the submission on July 13, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K882936 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1988
Decision Date January 09, 1989
Days to Decision 180 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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