510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842964Substantially Equivalent

Photic Stimulator Tm-3030-70

Tracor Northern, Inc., Middleton WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842964 is the FDA 510(k) clearance record for PHOTIC STIMULATOR TM-3030-70, a class II device, cleared for Tracor Northern, Inc. on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list 10 510(k) clearances for Tracor Northern, Inc., from to . As of , FDA records show no recalls naming K842964.

Clearance record

Decision date
Received
(154 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Tracor Northern, Inc. 2551 W. Beltline Hwy., Middleton WI
Third party review
No

Clearances, product code GWE

Trailing 12 months

FDA records hold no clearances under product code GWE in the trailing twelve months.

FDA records show no clearances under product code GWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260