510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K013977Substantially Equivalent

Echo-Screen T, Ta, Td, Tda, Tc

Fischer-Zoth Audiologic Systems, Inc., Riverton UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013977 is the FDA 510(k) clearance record for ECHO-SCREEN T, TA, TD, TDA, TC, a class II device, cleared for Fischer-Zoth Audiologic Systems, Inc. on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 2 510(k) clearances for Fischer-Zoth Audiologic Systems, Inc., from to . As of , FDA records show no recalls naming K013977.

Clearance record

Decision date
Received
(193 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Fischer-Zoth Audiologic Systems, Inc. 1257 W. Margaret View Cir., Riverton UT
510(k) summary
Summary
Third party review
No

Clearances, product code GWJ

Trailing 12 months

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

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