Cleared Traditional

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000

K962714 · Passy-Muir, Inc. · Anesthesiology
Oct 1996
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K962714 is an FDA 510(k) clearance for the PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000, 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 October 28, 1996, 108 days after receiving the submission on July 12, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K962714 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1996
Decision Date October 28, 1996
Days to Decision 108 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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