Cleared Traditional

INVACARE'S TWILIGHT II NASAL MASKS

K061874 · Invacare Corp. · Anesthesiology
Sep 2006
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K061874 is an FDA 510(k) clearance for the INVACARE'S TWILIGHT II NASAL MASKS, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on September 5, 2006, 64 days after receiving the submission on July 3, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K061874 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2006
Decision Date September 05, 2006
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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