510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130201Substantially Equivalent

Nystagram Video Nystagmography System

Ototronix, LLC, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130201 is the FDA 510(k) clearance record for NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM, a class II device, cleared for Ototronix, LLC on under FDA product code GWN (Nystagmograph). FDA records list 2 510(k) clearances for Ototronix, LLC, from to . As of , FDA records show no recalls naming K130201.

Clearance record

Decision date
Received
(88 days to decision)
Product code
GWN Nystagmograph
Regulation
21 CFR 882.1460
Device class
Class II
Review panel
Neurology
Applicant
Ototronix, LLC 4486 Timberline Ct., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWN

Trailing 12 months
1 clearance under product code GWN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260