Cleared Traditional

INVACARE PASSOVER HUMIDIFIER MODEL ISP9700

K003561 · Invacare Corp. · Anesthesiology
Apr 2001
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K003561 is an FDA 510(k) clearance for the INVACARE PASSOVER HUMIDIFIER MODEL ISP9700, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on April 17, 2001, 148 days after receiving the submission on November 20, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K003561 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2000
Decision Date April 17, 2001
Days to Decision 148 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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