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510(k) Data Aggregation
K Number
K213170Device Name
SENSOSEEG Depth Electrodes
Manufacturer
Sensomedical Labs LTD
Date Cleared
2023-04-18
(567 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
Sensomedical Labs LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Senso Medical Depth Electrodes are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Device Description
The SENSO SEEG Electrode is a smooth electrode with a diameter of 0.8 - 2 mm with a rounded tip. Different configurations exist with diameters of 0.8, 1.1, 1.27, and 2.0 mm. The electrode contacts are made from stainless-steel that can be 1.5mm, 2.0, and 3.0 mm long, with a total exploration length varying from (22 - 82 mm) according to the electrode reference. The total length of the electrodes range from 360 mm to 410 mm long depending on the number of contacts and total exploration length of the electrodes. The electrodes come in 3 main configurations, but can be customized to the parameters mentioned above based on the application need.
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