FDA.reportPublic FDA data

510(k) K223775

Device
EZ-STIK Electrodes
Applicant
South Dakota Partners
510(k) number
K223775
Product code
GXY
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-03
Date received
2022-12-16
Regulation
882.1320
Classification name
Electrode, Cutaneous
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Mike Plunkett
Address
205 Hwy. 22 E Clear Lake SD US 57226 57226

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXY#

510(k), Device, Applicant table
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K241160CAIs Sensor (CAIs-001)Brainu Co., Ltd.2024-12-13