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510(k) Data Aggregation
K Number
K041917Device Name
PLASIATEK ACTUATOR
Manufacturer
Date Cleared
2005-01-07
(175 days)
Product Code
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
PLASIATEK, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using Doppler ultrasound imaging.
Device Description
The PlasiaTEK™ Actuator Device is a small, non-invasive, battery operated vibrating accessory with an on/off switch that is attached to the ventilation circuit connector on the proximal end of an endotracheal tube. The PlasiaTEK Actuator is used in combination with a previously cleared-to-market endotracheal tube and standard Doppler ultrasound system to locate the endotracheal tube within the trachea. When turned on, the Actuator slightly vibrates the tube. An imaging Doppler ultrasound system can detect the endotracheal tube position because of the gentle small motion caused by the PlasiaTEK Actuator.
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