Cleared Traditional

INVACARE POLARIS EX CPAP, MODEL ISP3000

K031064 · Invacare Corp. · Anesthesiology
Mar 2004
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K031064 is an FDA 510(k) clearance for the INVACARE POLARIS EX CPAP, MODEL ISP3000, 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 March 12, 2004, 344 days after receiving the submission on April 3, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K031064 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2003
Decision Date March 12, 2004
Days to Decision 344 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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