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510(k) Data Aggregation
K Number
K190536Device Name
Mediracer NCS
Manufacturer
Mediracer Oy
Date Cleared
2019-09-25
(205 days)
Product Code
JXE
Regulation Number
882.1550Why did this record match?
Applicant Name (Manufacturer) :
Mediracer Oy
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mediracer NCS is intended to measure sensory and motor neripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.
Device Description
The Mediracer NCS is a hand-held NCS Device to stimulate and record the nerve responses from patient. The NCS Device is connected to the disposable surface electrodes with cables provided with the NCS Device. The NCS Device communicates via Bluetooth with a computer which is using The Mediracer Analysis Center (MAC) software. The computer uses the MAC software to store and handle the patient measurement data. With the NCS Device comes a charger and a docking station for charging the NCS Device. Also, solution includes a test module for checking the functionality of the whole test system.
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