Cleared Traditional

THERA-MIST HUMIDIFIER

K894000 · Pegasus Research Corp. · Anesthesiology
Aug 1989
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K894000 is an FDA 510(k) clearance for the THERA-MIST HUMIDIFIER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on August 28, 1989, 84 days after receiving the submission on June 5, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K894000 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1989
Decision Date August 28, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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