Cleared Traditional

TWILIGHT FULL FACE MASK

K070321 · Invacare Corp. · Anesthesiology
Apr 2007
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K070321 is an FDA 510(k) clearance for the TWILIGHT FULL FACE MASK, 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 April 30, 2007, 87 days after receiving the submission on February 2, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K070321 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2007
Decision Date April 30, 2007
Days to Decision 87 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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