Devices · Infinite Biomedical Technologies, LLC

Sense System with IBT Electrodes

510(k)K182112NeurologyGXY

Infinite Biomedical Technologies, LLC is listed for Sense System with IBT Electrodes (K182112). The FDA list gives October 5, 2018 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GXY. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182112

Official FDA database record

Date of final decision: October 5, 2018
Company on the FDA list: Infinite Biomedical Technologies, LLC
Lead panel: Neurology
Primary product code: GXY
openFDA device name for the code: Electrode, Cutaneous
Device class: 2
Regulation number: 882.1320
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary