510(k) K230073

Okti by Compumedics Limited — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 9, 2023
Date Received: January 10, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Full-Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

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

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K093223 — COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG (January 15, 2010)
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K021176 — COMPUMEDICS SOMTE SYSTEM (January 21, 2003)
K003175 — COMPUMEDICS SIESTA SYSTEM (December 27, 2000)

Other clearances for product code GWQ

K260455 — New Wave System (March 13, 2026)
K233403 — Flexset System (April 30, 2024)
K231366 — Neuronaute Plus (November 9, 2023)
K221959 — Q21 (August 31, 2023)
K231457 — SPARK Scan (August 18, 2023)
K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
K220056 — iSyncWave (August 10, 2022)
K212788 — Seer Home (June 16, 2022)
K213900 — WAVi SCAN EEG System and Accessories (May 6, 2022)