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510(k) Data Aggregation
K Number
K140680Device Name
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
Manufacturer
Date Cleared
2014-12-12
(269 days)
Product Code
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
ALPINE BIOMED APS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Leadpoint Focus microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes.
The Leadpoint Focus microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.
Device Description
Intraoperative microelectrode recording (MER) has been introduced to improve the target localization during stereotactic surgery. The Leadpoint Focus is a MER system which consists of the Leadpoint Focus Software, Focus Hardware, a Macro Stimulator, a MER amplifier and a sterile interconnection cable (MER Cable) that connects the system to a Microelectrode. The Microelectrode is supplied by another manufacturer and is not part of the Leadpoint Focus system.
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