Cleared Traditional

K920306 - OPTI-MOL FILTERED PUNCTURE PIN
(FDA 510(k) Clearance)

K920306 · Automatic Liquid Packaging, Inc. · Anesthesiology
Apr 1992
Decision
75d
Days
Class 2
Risk

K920306 is an FDA 510(k) clearance for the OPTI-MOL FILTERED PUNCTURE PIN, 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 April 6, 1992, 75 days after receiving the submission on January 22, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K920306 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1992
Decision Date April 06, 1992
Days to Decision 75 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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