Cleared Traditional

HUMIDIFIER ADAPTER

K962079 · Automatic Liquid Packaging, Inc. · Anesthesiology
Jul 1996
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K962079 is an FDA 510(k) clearance for the HUMIDIFIER ADAPTER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on July 31, 1996, 64 days after receiving the submission on May 28, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K962079 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1996
Decision Date July 31, 1996
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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