MERIDIAN-II AND MERDIAN-PLUS

Device, Galvanic Skin Response Measurement

MERIDIAN CO., LTD.

The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Meridian-ii And Merdian-plus.

Pre-market Notification Details

Device IDK001347
510k NumberK001347
Device Name:MERIDIAN-II AND MERDIAN-PLUS
ClassificationDevice, Galvanic Skin Response Measurement
Applicant MERIDIAN CO., LTD. 9FI SEOIL BLDG 222 JAMSILBON-DONG Songpa-gu, Seoul,  KR
ContactSoo-rang Lee
CorrespondentSoo-rang Lee
MERIDIAN CO., LTD. 9FI SEOIL BLDG 222 JAMSILBON-DONG Songpa-gu, Seoul,  KR
Product CodeGZO  
CFR Regulation Number882.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-28
Decision Date2000-11-03

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