Cleared Traditional

THERA-MIST(TM) NEBULIZER, MODEL 30000

K893942 · Pegasus Research Corp. · Anesthesiology
Aug 1989
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K893942 is an FDA 510(k) clearance for the THERA-MIST(TM) NEBULIZER, MODEL 30000, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on August 28, 1989, 89 days after receiving the submission on May 31, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K893942 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1989
Decision Date August 28, 1989
Days to Decision 89 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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