Cleared Traditional

SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER

K862042 · Associated Mills, Inc. · Anesthesiology
Jun 1986
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K862042 is an FDA 510(k) clearance for the SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on June 5, 1986, 8 days after receiving the submission on May 28, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number K862042 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1986
Decision Date June 05, 1986
Days to Decision 8 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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