Cleared Traditional

THERA-MIST NEBULIZER MODEL-P3000

K962534 · Pegasus Research Corp. · Anesthesiology
Feb 1997
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K962534 is an FDA 510(k) clearance for the THERA-MIST NEBULIZER MODEL-P3000, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pegasus Research Corp. (Santa Ana, US). The FDA issued a Cleared decision on February 28, 1997, 245 days after receiving the submission on June 28, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K962534 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1996
Decision Date February 28, 1997
Days to Decision 245 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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