Cleared Traditional

HEATED HUMIDIFIER

K983783 · Pegasus Research Corp. · Anesthesiology
Oct 2000
Decision
728d
Days
Class 2
Risk

About This 510(k) Submission

K983783 is an FDA 510(k) clearance for the HEATED HUMIDIFIER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Pegasus Research Corp. (Santa Ana, US). The FDA issued a Cleared decision on October 24, 2000, 728 days after receiving the submission on October 27, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K983783 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1998
Decision Date October 24, 2000
Days to Decision 728 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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