Cleared Abbreviated

IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

K022062 · Impact Instrumentation, Inc. · Anesthesiology
May 2003
Decision
315d
Days
Class 2
Risk

About This 510(k) Submission

K022062 is an FDA 510(k) clearance for the IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on May 6, 2003, 315 days after receiving the submission on June 25, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K022062 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2002
Decision Date May 06, 2003
Days to Decision 315 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MOD — Accessory To Continuous Ventilator (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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