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510(k) K111308

Device
ZYTO HAND CRADLE
Applicant
ZYTO TECHNOLOGIES, INC
510(k) number
K111308
Product code
GZO  
Decision
Substantially Equivalent (SESE)
Decision date
2011-08-30
Date received
2011-05-10
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
VAUGHN R COOK
Address
387 S. 520 W. Suite 200 Lindon UT US 84042 84042

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
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
K020360ABR-2000Meridian Co., Ltd.2002-08-29
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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