Cleared Traditional

MEDSHIELD/AEROCHAMBER

K961455 · Diemolding Corp. · Anesthesiology
Jul 1996
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K961455 is an FDA 510(k) clearance for the MEDSHIELD/AEROCHAMBER, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on July 25, 1996, 100 days after receiving the submission on April 16, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number K961455 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1996
Decision Date July 25, 1996
Days to Decision 100 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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