Cleared Traditional

USE 77 ULTRASONIC NEBULIZER

K832086 · Medlog GmbH Marketing Services · Anesthesiology
Jul 1983
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K832086 is an FDA 510(k) clearance for the USE 77 ULTRASONIC NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Medlog GmbH Marketing Services (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 21 days after receiving the submission on June 28, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K832086 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1983
Decision Date July 19, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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