Cleared Traditional

AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED

K915890 · Pegasus Research Corp. · Anesthesiology
Jun 1992
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K915890 is an FDA 510(k) clearance for the AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED, 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 June 24, 1992, 183 days after receiving the submission on December 24, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K915890 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1991
Decision Date June 24, 1992
Days to Decision 183 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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