Cleared Traditional

VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX

K002284 · Invacare Corp. · Anesthesiology
Oct 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K002284 is an FDA 510(k) clearance for the VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX, a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on October 24, 2000, 90 days after receiving the submission on July 26, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K002284 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2000
Decision Date October 24, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NFB — Conserver, Oxygen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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