Cleared Traditional

MICROCIRRUS MEDICAL NEBULIZER

K881935 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology
Jun 1988
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K881935 is an FDA 510(k) clearance for the MICROCIRRUS MEDICAL NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on June 22, 1988, 44 days after receiving the submission on May 9, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K881935 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1988
Decision Date June 22, 1988
Days to Decision 44 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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