Cleared Traditional

PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)

K944451 · Passy-Muir, Inc. · Anesthesiology
Jul 1995
Decision
298d
Days
Class 2
Risk

About This 510(k) Submission

K944451 is an FDA 510(k) clearance for the PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES), a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Passy-Muir, Inc. (Irvine, US). The FDA issued a Cleared decision on July 7, 1995, 298 days after receiving the submission on September 12, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K944451 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1994
Decision Date July 07, 1995
Days to Decision 298 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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