Cleared Traditional

RHINO-GUARD

K911785 · Micromedics, Inc. · Anesthesiology
Oct 1991
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K911785 is an FDA 510(k) clearance for the RHINO-GUARD, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 7, 1991, 168 days after receiving the submission on April 22, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K911785 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1991
Decision Date October 07, 1991
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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