Cleared Traditional

MAXI-NEB

K852627 · Ashai Co. , Ltd. · Anesthesiology
Sep 1985
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K852627 is an FDA 510(k) clearance for the MAXI-NEB, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on September 26, 1985, 98 days after receiving the submission on June 20, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number K852627 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1985
Decision Date September 26, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5640

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