Home / 510(k) Clearances / K093223

510(k) K093223

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG by Compumedics Limited — Product Code GWQ

K093223 is an FDA 510(k) premarket notification submitted by Compumedics Limited for the device "COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG". The FDA issued a decision of Substantially Equivalent on January 15, 2010. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Compumedics Limited has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2010
Date Received
October 13, 2009
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

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 by Compumedics Limited

  • K252383 — Somfit D (August 28, 2025)
  • K242447 — Falcon HST (February 20, 2025)
  • K231546 — Somfit (November 30, 2023)
  • K230073 — Okti (February 9, 2023)
  • K191785 — Orion LifeSpan MEG (February 14, 2020)
  • K072201 — COMPUMEDICS SOMTE PSG RECORDING SYSTEM (April 14, 2008)
  • K021176 — COMPUMEDICS SOMTE SYSTEM (January 21, 2003)
  • K003175 — COMPUMEDICS SIESTA SYSTEM (December 27, 2000)

Other clearances for product code GWQ

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • 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)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)

FDA data resources