510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811772Substantially Equivalent

Auditory Localizer

Western Advanced Technology, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811772 is the FDA 510(k) clearance record for AUDITORY LOCALIZER, a class II device, cleared for Western Advanced Technology, Inc. on under FDA product code ETS (Generator, Electronic Noise (For Audiometric Testing)). FDA records list 6 510(k) clearances for Western Advanced Technology, Inc., from to . As of , FDA records show no recalls naming K811772.

Clearance record

Decision date
Received
(23 days to decision)
Product code
ETS Generator, Electronic Noise (For Audiometric Testing)
Regulation
21 CFR 874.1120
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Western Advanced Technology, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ETS

Trailing 12 months

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

FDA records show no clearances under product code ETS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ETS, 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