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510(k) Data Aggregation
K Number
K062104Device Name
TALKING TRACH
Manufacturer
ENGINEERED MEDICAL SYSTEMS, INC.
Date Cleared
2007-04-20
(270 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients. For adult patients > 30 kg.
Device Description
The proposed EMS Talking Trach is a tracheostomy tube which allows patients who are ventilator dependent or spontaneously breathing to speak or phonate. It can be used with patients on ventilators while the cuff is "up" or inflated. It is offered in sizes from 4.0 to 10.0 mm with disposable standard and speaking inner cannula.
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