Cleared Traditional

RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE

K955238 · Rusch Intl. · Anesthesiology
Feb 1996
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K955238 is an FDA 510(k) clearance for the RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE, a Stylet, Tracheal Tube (Class I — General Controls, product code BSR), submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on February 6, 1996, 84 days after receiving the submission on November 14, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5790.

Submission Details

510(k) Number K955238 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1995
Decision Date February 06, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSR — Stylet, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5790

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