Cleared Traditional

PRECISION MIST COMPRESSOR

K923324 · Precision Medical, Inc. · Anesthesiology
Jan 1993
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K923324 is an FDA 510(k) clearance for the PRECISION MIST COMPRESSOR, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on January 14, 1993, 191 days after receiving the submission on July 7, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K923324 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1992
Decision Date January 14, 1993
Days to Decision 191 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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