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510(k) K020360

Device
ABR-2000
Applicant
MERIDIAN CO., LTD.
510(k) number
K020360
Product code
GZO  
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-29
Date received
2002-02-04
Regulation
882.1540
Classification name
Device, Galvanic Skin Response Measurement
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SOO-RANG LEE
Address
9fi Seoil Bldg 222 Jamsilbon-Dong Songpa-Gu, Seoul KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GZO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150804QBioScanMedeia, Inc.2015-10-19
K152216SudoCLd Technology, LLC2015-09-24
K141872SUDOSCANImpeto Medical, Inc.2014-11-21
K131568SUDO PATHLd Technology, LLC2013-06-28
K111308ZYTO HAND CRADLEZyto Technologies, Inc.2011-08-30
K102166ELECTRO INTERSTITIAL SCANLd Technology, LLC2010-12-10
K100233SUDOSCANImpeto Medical2010-06-14
K053004MSAS-VANTAGEBiomeridian, Int.2006-01-13
K032935EPI-SCAN, MODEL P 100Edx Epi-Scan, Inc.2003-11-20
K023355ASYRAGalloway Technologies, LLC2003-06-24
K020567AKUPORT M1Vibrant Health2002-05-02
K020564EAV KINDLING 2000S GSR DEVICEVirbrant Health2002-04-30
K020565EAV COMBI-2Vibrant Health2002-04-30
K020568AKUPORT M-2Vibrant Health2002-04-30
K010897MERIDIAN-PORTABLEMeridian Co., Ltd.2001-06-19

Legacy Summary#

summary

FDA Review#

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