510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173936Substantially Equivalent

Natus Photic Stimulator

Natus Medical Incorporated, Oakville, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173936 is the FDA 510(k) clearance record for Natus Photic Stimulator, a class II device, cleared for Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list 23 510(k) clearances for Natus Medical Incorporated, from to . As of , FDA records show no recalls naming K173936.

Clearance record

Decision date
Received
(171 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 2568 Bristol Cir., Oakville, CA
510(k) summary
Summary PDF
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