ELEKTA NEUROMAG WITH MAXWELL FILTER— 510(k) K050035

Name: FDA 510(k) clearance K050035
Creator: U.S. Food and Drug Administration
Published: 2005-01-25

Substantially Equivalent

Elekta Neuromag OY

FDA 510(k) clearance K050035 for ELEKTA NEUROMAG WITH MAXWELL FILTER, Substantially Equivalent on 2005-01-25. 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: 2005-01-07
Decision date: 2005-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

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