Cleared Traditional

SULLIVAN HUMIDAIRE HEATED HUMIDIFIER

K971260 · ResMed Corp · Anesthesiology
Sep 1997
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K971260 is an FDA 510(k) clearance for the SULLIVAN HUMIDAIRE HEATED HUMIDIFIER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on September 4, 1997, 153 days after receiving the submission on April 4, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K971260 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1997
Decision Date September 04, 1997
Days to Decision 153 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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