510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003644Substantially Equivalent

Eyetect Tremor Monitor Unit (Tmu)

Eyetect, LLC, Belleville, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003644 is the FDA 510(k) clearance record for EYETECT TREMOR MONITOR UNIT (TMU), a class II device, cleared for Eyetect, LLC on under FDA product code GWN (Nystagmograph). FDA records list one 510(k) clearance for Eyetect, LLC. As of , FDA records show no recalls naming K003644.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GWN Nystagmograph
Regulation
21 CFR 882.1460
Device class
Class II
Review panel
Neurology
Applicant
Eyetect, LLC 10 Madonna Ct., Belleville, IL
510(k) summary
Summary
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