Cleared Traditional

AERO-MIST NEBULIZER HEATER

K880473 · Pegasus Research Corp. · Anesthesiology
Mar 1988
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K880473 is an FDA 510(k) clearance for the AERO-MIST NEBULIZER HEATER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pegasus Research Corp. (Corona Del Mar, US). The FDA issued a Cleared decision on March 31, 1988, 56 days after receiving the submission on February 4, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K880473 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1988
Decision Date March 31, 1988
Days to Decision 56 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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