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510(k) K250601

Neuro Omega System; NeuroSmart System by Alpha Omega Engineering , Ltd. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2025
Date Received
February 28, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Alpha Omega Engineering , Ltd.

  • K220553 — Neuro Omega System, NeuroSmart System (September 16, 2022)
  • K191739 — Sterile LeadConfirm (January 2, 2020)
  • K172042 — NeuroNav System, NeuroSmart System (February 27, 2018)
  • K171581 — Neuro Omega System (December 22, 2017)
  • K123796 — NEURO OMEGA SYSTEM (April 5, 2013)
  • K120098 — STERILE DISPOSABLES FOR MER (June 12, 2012)
  • K052527 — NEUROPROBES (April 12, 2006)
  • K813333 — ALPHATEMP CLINICAL THERMOMETER (December 31, 1981)

Other clearances for product code GZL

  • K250363 — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12 (November 5, 2025)
  • K223269 — Spencer Probe Depth Electrodes (May 18, 2023)
  • K223276 — Anchor Bolts as Accessories to Depth Electrodes (May 18, 2023)
  • 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)
  • K201678 — iCE-SG Subcutaneous Electrode Arrays (March 8, 2021)