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510(k) Data Aggregation
K Number
K021118Device Name
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
Manufacturer
CLASS A ENT.
Date Cleared
2002-05-28
(50 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
CLASS A ENT.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electromyographic (EMG) needle electrodes are intended to be placed into the muscle or nerve tissue to sense bioelectrical signals. This monopolar needle is an accessory to the electromyography machine, which is used for assessing a series of skeletal muscles. EMG electrodes are for use under the proper direction of a licensed physician and intended for single patient use, only.
Device Description
Detachable Monopolar EMG Needle Electrode
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K Number
K982053Device Name
EEG ELECTRODES MODEL 445 SERIES
Manufacturer
CLASS A ENT.
Date Cleared
1999-04-20
(313 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
CLASS A ENT.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EEG Electrodes Model "445 Series" will be used to record the surface EEG potentials of the brain.
Device Description
Not Found
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