COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG— 510(k) K093223

Name: FDA 510(k) clearance K093223
Creator: U.S. Food and Drug Administration
Published: 2010-01-15

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K093223 for COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG, Substantially Equivalent on 2010-01-15. Applicant: Compumedics Limited. Device class: 2.

Clearance details

Applicant: Compumedics Limited
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2009-10-13
Decision date: 2010-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbotsford, Victoria, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWQ

view all

K261604 — Enobio Dx (3 models)2026-06-13
K260455 — New Wave System2026-03-13
K233403 — Flexset System2024-04-30
K231366 — Neuronaute Plus2023-11-09
K221959 — Q212023-08-31

More clearances from Compumedics Limited

view all

K252383 — Somfit D2025-08-28
K242447 — Falcon HST2025-02-20
K231546 — Somfit2023-11-30
K230073 — Okti2023-02-09
K191785 — Orion LifeSpan MEG2020-02-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.