ELEKTA NEUROMAG WITH MAXFILTER— 510(k) K091393

Name: FDA 510(k) clearance K091393
Creator: U.S. Food and Drug Administration
Published: 2010-10-26

Substantially Equivalent

Elekta Neuromag OY

FDA 510(k) clearance K091393 for ELEKTA NEUROMAG WITH MAXFILTER, Substantially Equivalent on 2010-10-26. Applicant: Elekta Neuromag OY. Device class: 2.

Clearance details

Applicant: Elekta Neuromag OY
Product code: Code OLX
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2009-05-11
Decision date: 2010-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLX

view all

K260563 — CN-Suite2026-08-16
K252565 — PreOp v32026-02-13
K250239 — NeuroMatch2025-05-23
K241513 — Sourcerer2024-09-27
K233985 — TRIUX neo (NM27000N ); MEGreview (SW26241N-B)2024-05-15

More clearances from Elekta Neuromag OY

view all

K081430 — ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING2008-07-28
K050035 — ELEKTA NEUROMAG WITH MAXWELL FILTER2005-01-25
K041264 — ELEKTA OY2004-08-10

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