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510(k) K180761

SD LTM STIM Cortical Stimulator by Micromed S.P.A. — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2018
Date Received
March 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type

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  • K914762 — MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR (December 5, 1991)
  • K882980 — REBUILDER BUCKET SYSTEM (April 24, 1989)
  • K874085 — REBUILDER(TM) (December 11, 1987)

Other clearances for product code GYC

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  • K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (October 2, 2021)
  • K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (February 14, 2020)
  • K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid (January 25, 2020)
  • K192764 — NeuroOne Cortical Electrode (November 26, 2019)
  • K183437 — AirRay Subdural Cortical Electrodes (March 12, 2019)
  • K173684 — g.Estim PRO (May 4, 2018)