NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM

Nystagmograph

OTOTRONIX, LLC

The following data is part of a premarket notification filed by Ototronix, Llc with the FDA for Nystagram Video Nystagmography System.

Pre-market Notification Details

Device IDK130201
510k NumberK130201
Device Name:NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
ClassificationNystagmograph
Applicant OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul,  MN  55127
ContactBernard Horwath
CorrespondentBernard Horwath
OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul,  MN  55127
Product CodeGWN  
CFR Regulation Number882.1460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-28
Decision Date2013-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B366VN1061 K130201 000

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