NYSTAGMOGRAPH EOG/ENG ANALYSES

Nystagmograph

NICOLET BIOMEDICAL INSTRUMENTS

The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nystagmograph Eog/eng Analyses.

Pre-market Notification Details

Device IDK851190
510k NumberK851190
Device Name:NYSTAGMOGRAPH EOG/ENG ANALYSES
ClassificationNystagmograph
Applicant NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison,  WI  53711
ContactRon Luich
CorrespondentRon Luich
NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison,  WI  53711
Product CodeGWN  
CFR Regulation Number882.1460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-26
Decision Date1985-11-27

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