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Found 2 results
510(k) Data Aggregation
K Number
K120098Device Name
STERILE DISPOSABLES FOR MER
Manufacturer
ALPHA OMEGA ENGINEERING, LTD.
Date Cleared
2012-06-12
(152 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
ALPHA OMEGA ENGINEERING, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Omega's Sterile Disposable NeuroProbes for MER devices are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's sterile Disposable Cannulas for MER are intended for guiding the NeuroProbes in Neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's Sterile Disposable Recording Cables for MER are intended to be used in neurosurgery for connecting NeuroProbes to recording and stimulation device.
Alpha Omega's Sterile Disposable NeuroProbes, Cannulas and Recording Cables for MER are indicated for assisting Neurosurgeons, in the operation room during functional neurosurgery, to aid in placement of depth electrodes.
Device Description
Sterile Disposables for MER
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K Number
K052527Device Name
NEUROPROBES
Manufacturer
ALPHA OMEGA ENGINEERING, LTD.
Date Cleared
2006-04-12
(212 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
ALPHA OMEGA ENGINEERING, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Omega NeuroProbes are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Device Description
Not Found
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