DAEHAN MEDICAL SYSTEMS CO., LTD

Address:250 Okgucheondong-ro,Siheung-City Gyeonggi,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Cutaneous (GXY) (1)

Premarket Exempt

Clear

DAEHAN Disposable cup electrode - 08800036901829 Catalog Number :

Device Description : DAEHAN Disposable CUP Electrodes are intended for non-invasive use with recordin DAEHAN Disposable CUP Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography(EMG), Electroencephalograph (EEG) and Evoked potentials(EP).

Device Class : 2

Duns Number: 688038491

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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