Cleared Traditional

THE INVACARE FLYER, MODEL IPC 100

K071928 · Invacare Corp. · Anesthesiology
Dec 2007
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K071928 is an FDA 510(k) clearance for the THE INVACARE FLYER, MODEL IPC 100, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on December 12, 2007, 153 days after receiving the submission on July 12, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K071928 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2007
Decision Date December 12, 2007
Days to Decision 153 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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