Cleared Traditional

NEBULIZER HEATER

K882935 · Automatic Liquid Packaging, Inc. · Anesthesiology
Dec 1988
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K882935 is an FDA 510(k) clearance for the NEBULIZER HEATER, 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 December 27, 1988, 167 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 K882935 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1988
Decision Date December 27, 1988
Days to Decision 167 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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