Cleared Traditional

HUMIDIFIER W/ OR W/OUT ADAPTOR

K811161 · Airlife, Inc. · Anesthesiology
Jun 1981
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K811161 is an FDA 510(k) clearance for the HUMIDIFIER W/ OR W/OUT ADAPTOR, 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 June 24, 1981, 57 days after receiving the submission on April 28, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number K811161 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1981
Decision Date June 24, 1981
Days to Decision 57 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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