NYSTAGMOGRAPH EOG/ENG ANALYSES— 510(k) K851190

Substantially Equivalent

Nicolet Biomedical Instruments

FDA 510(k) clearance K851190 for NYSTAGMOGRAPH EOG/ENG ANALYSES, Substantially Equivalent on 1985-11-27. Applicant: Nicolet Biomedical Instruments. Device class: 2.

Clearance details

Applicant
Nicolet Biomedical Instruments
Product code
Code GWN
Device class
Class 2
Regulation
21 CFR 882.1460
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Madison, WI, US
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