Cleared Traditional

RUSCH EDGAR TUBE

K021540 · Rusch Intl. · Anesthesiology
Aug 2002
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K021540 is an FDA 510(k) clearance for the RUSCH EDGAR TUBE, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on August 1, 2002, 83 days after receiving the submission on May 10, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K021540 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2002
Decision Date August 01, 2002
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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