510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K943215Substantially Equivalent

Disposable Audiometer Earphone Cushion Cover

Kenneth Ullrich, Wenatchee WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943215 is the FDA 510(k) clearance record for DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER, a class II device, cleared for Kenneth Ullrich on under FDA product code EWO (Audiometer). FDA records list one 510(k) clearance for Kenneth Ullrich. As of , FDA records show no recalls naming K943215.

Clearance record

Decision date
Received
(311 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Kenneth Ullrich 4369 Anna Ln., Wenatchee WA
510(k) summary
Summary
Third party review
No

Clearances, product code EWO

Trailing 12 months

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

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