Cleared Traditional

INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02

K020386 · Invacare Corp. · Anesthesiology
Jul 2002
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K020386 is an FDA 510(k) clearance for the INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02, 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 2, 2002, 146 days after receiving the submission on February 6, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K020386 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2002
Decision Date July 02, 2002
Days to Decision 146 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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