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510(k) K071364

MICROTARGETING GUIDELINE 4000 by FHC, Inc. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2007
Date Received
May 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

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Other clearances for product code GZL

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  • K213170 — SENSOSEEG Depth Electrodes (April 18, 2023)
  • K222706 — iCE-SG2 Subcutaneous Electrode Kit (December 6, 2022)
  • K222404 — Evo® sEEG System (October 20, 2022)
  • K220553 — Neuro Omega System, NeuroSmart System (September 16, 2022)
  • K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes (November 18, 2021)
  • K211367 — Evo sEEG System (September 1, 2021)