Cleared Traditional

WH150 ROOM HUMIDIFIER

K871661 · Associated Mills, Inc. · Anesthesiology
Jun 1987
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K871661 is an FDA 510(k) clearance for the WH150 ROOM 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 15, 1987, 48 days after receiving the submission on April 28, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number K871661 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1987
Decision Date June 15, 1987
Days to Decision 48 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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