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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 K001347
Device Name MERIDIAN-II AND MERDIAN-PLUS
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 Received04/28/2000
Decision Date 11/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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