510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844616Substantially Equivalent

Siegen Visual Stimulator

Siegen Corp., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844616 is the FDA 510(k) clearance record for SIEGEN VISUAL STIMULATOR, a class II device, cleared for Siegen Corp. on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list 6 510(k) clearances for Siegen Corp., from to . As of , FDA records show no recalls naming K844616.

Clearance record

Decision date
Received
(79 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Siegen Corp. 2400 Bayshore Frontage Rd., Mountain View CA
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