510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K994254Substantially Equivalent

Interacoustics At235 Impedance Audiometer

International Distributors of Electronics for Medi, Benicia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994254 is the FDA 510(k) clearance record for INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER, a class II device, cleared for International Distributors of Electronics For Medi on under FDA product code ETY (Tester, Auditory Impedance). FDA records list one 510(k) clearance for International Distributors of Electronics For Medi. As of , FDA records show no recalls naming K994254.

Clearance record

Decision date
Received
(88 days to decision)
Product code
ETY Tester, Auditory Impedance
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
International Distributors of Electronics For Medi 4814 E. Second St., Benicia CA
510(k) summary
Summary
Third party review
No

Clearances, product code ETY

Trailing 12 months

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

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