Cleared Traditional

MP-500 ELECTRONIC NEBULIZER

K862171 · The Timeter Group · Anesthesiology
Jul 1986
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K862171 is an FDA 510(k) clearance for the MP-500 ELECTRONIC NEBULIZER, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by The Timeter Group (Lancaster, US). The FDA issued a Cleared decision on July 14, 1986, 35 days after receiving the submission on June 9, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number K862171 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1986
Decision Date July 14, 1986
Days to Decision 35 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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