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510(k) K190050

Tech Dots - Adhesive and conductive gel by Spes Medica Srl — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2019
Date Received
January 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

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  • K192603 — Spes Medica Subdermal Needle Electrodes (November 22, 2019)
  • K133348 — STIM PROBE (November 21, 2014)
  • K120494 — DISPOSABLE ADHESIVE SURFACE ELECTRODE (June 11, 2012)
  • K093373 — LARYNGEAL SURFACE ELECTRODE (August 24, 2010)
  • K091410 — DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (August 11, 2009)

Other clearances for product code GYB

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  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)