Cleared Traditional

VENTURE HOMEFILL II WITH OXYGEN CONSERVER

K021685 · Invacare Corp. · Anesthesiology
Jul 2002
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K021685 is an FDA 510(k) clearance for the VENTURE HOMEFILL II WITH OXYGEN CONSERVER, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on July 23, 2002, 62 days after receiving the submission on May 22, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K021685 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2002
Decision Date July 23, 2002
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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