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510(k) Data Aggregation
K Number
K082404Device Name
NAVIGATION PROBES
Manufacturer
Date Cleared
2009-02-25
(188 days)
Product Code
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
WE SENSE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
We Sense Navigation Probes electrodes are intended to be used in operation room during neurosurgery for temporary (less than two hours) recording and stimulation of defined small area in the brain, and for recording electrical signals from target brain cells. These electrodes can be used only by professional staff and not sell over the counter
Device Description
NavigationProbes are equipped with a Micro tip and a Macro tip. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for MicroStimulation. The Macro tip is used for stimulation and recording of local field potentials.
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