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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K020360
Device Name ABR-2000
Applicant
Meridian Co., Ltd.
9fi Seoil Bldg
222 Jamsilbon-Dong
Songpa-Gu, Seoul,  KR
Applicant Contact SOO-RANG LEE
Correspondent
Meridian Co., Ltd.
9fi Seoil Bldg
222 Jamsilbon-Dong
Songpa-Gu, Seoul,  KR
Correspondent Contact SOO-RANG LEE
Regulation Number882.1540
Classification Product Code
GZO  
Date Received02/04/2002
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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