Cleared Traditional

AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000

K914465 · Pegasus Research Corp. · Anesthesiology
Mar 1992
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K914465 is an FDA 510(k) clearance for the AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000, 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 March 31, 1992, 176 days after receiving the submission on October 7, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K914465 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1991
Decision Date March 31, 1992
Days to Decision 176 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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