Cleared Traditional

OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM

K911770 · Automatic Liquid Packaging, Inc. · Anesthesiology
Oct 1991
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K911770 is an FDA 510(k) clearance for the OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM, 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 October 15, 1991, 179 days after receiving the submission on April 19, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K911770 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1991
Decision Date October 15, 1991
Days to Decision 179 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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