Cleared Traditional

PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

K962175 · Smiths Industries Medical Systems, Inc. · Anesthesiology
Jan 1997
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K962175 is an FDA 510(k) clearance for the PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on January 17, 1997, 226 days after receiving the submission on June 5, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K962175 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1996
Decision Date January 17, 1997
Days to Decision 226 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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