Cleared Traditional

#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY

K883593 · Ecolab, Inc. · Anesthesiology
Sep 1988
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K883593 is an FDA 510(k) clearance for the #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by Ecolab, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 30, 1988, 38 days after receiving the submission on August 23, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.

Submission Details

510(k) Number K883593 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1988
Decision Date September 30, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAE — Airway, Oropharyngeal, Anesthesiology
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5110

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