Cleared Traditional

VOLUME VENTILATOR CIRCUIT-NEBULIZER

K833196 · Airlife, Inc. · Anesthesiology
Nov 1983
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K833196 is an FDA 510(k) clearance for the VOLUME VENTILATOR CIRCUIT-NEBULIZER, a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I — General Controls, product code CAI), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983, 45 days after receiving the submission on September 19, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5240.

Submission Details

510(k) Number K833196 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1983
Decision Date November 03, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5240

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