Cleared Traditional

TWLIGHT, MODEL ISP 9600

K022642 · Invacare Corp. · Anesthesiology
Feb 2003
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K022642 is an FDA 510(k) clearance for the TWLIGHT, MODEL ISP 9600, 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 February 11, 2003, 187 days after receiving the submission on August 8, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K022642 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2002
Decision Date February 11, 2003
Days to Decision 187 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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