Cleared Traditional

HUMIDIFIER, WITH OR WITHOUT ADAPTER

K830896 · Airlife, Inc. · Anesthesiology
Apr 1983
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K830896 is an FDA 510(k) clearance for the HUMIDIFIER, WITH OR WITHOUT ADAPTER, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1983, 28 days after receiving the submission on March 21, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number K830896 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1983
Decision Date April 18, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code KFZ — Humidifier, Non-direct Patient Interface (home-use)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5460

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