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510(k) K170441

ElectroTek by Mobilemedtek — Product Code GWQ

K170441 is an FDA 510(k) premarket notification submitted by Mobilemedtek for the device "ElectroTek". The FDA issued a decision of Substantially Equivalent on Jun 5, 2017. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 5, 2017
Date Received
Feb 14, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type
510(k)

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances for product code GWQ

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  • K260455 — New Wave System (Mar 13, 2026)
  • K233403 — Flexset System (Apr 30, 2024)
  • K231366 — Neuronaute Plus (Nov 9, 2023)
  • K221959 — Q21 (Aug 31, 2023)
  • K231457 — SPARK Scan (Aug 18, 2023)
  • K221963 — Cumulus Functional Neurophysiology Platform (Apr 27, 2023)
  • K230073 — Okti (Feb 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (Jan 12, 2023)
  • K220056 — iSyncWave (Aug 10, 2022)

FDA data resources