BRAIN FUNCTION MAPPING OPTION FOR PATHF— 510(k) K843598

Name: FDA 510(k) clearance K843598
Creator: U.S. Food and Drug Administration
Published: 1985-04-11

Substantially Equivalent

Nicolet Biomedical Instruments

FDA 510(k) clearance K843598 for BRAIN FUNCTION MAPPING OPTION FOR PATHF, Substantially Equivalent on 1985-04-11. Applicant: Nicolet Biomedical Instruments. Device class: 2.

Clearance details

Applicant: Nicolet Biomedical Instruments
Product code: Code GWK
Device class: Class 2
Regulation: 21 CFR 882.1845
Advisory panel: Neurology
Date received: 1984-09-12
Decision date: 1985-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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