Cleared Traditional

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT

K990905 · Passy-Muir, Inc. · Anesthesiology
Jun 1999
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K990905 is an FDA 510(k) clearance for the PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT, 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 June 11, 1999, 85 days after receiving the submission on March 18, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K990905 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1999
Decision Date June 11, 1999
Days to Decision 85 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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