Cleared Traditional

TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO

K043160 · Tracoe Medical GmbH · Anesthesiology
Feb 2005
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K043160 is an FDA 510(k) clearance for the TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Tracoe Medical GmbH (Westborough, US). The FDA issued a Cleared decision on February 18, 2005, 95 days after receiving the submission on November 15, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K043160 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2004
Decision Date February 18, 2005
Days to Decision 95 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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