510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904622Substantially Equivalent

Hearing Checker(tm), Desktop Model

Qualitone Hearing Aids and Audiometers, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904622 is the FDA 510(k) clearance record for HEARING CHECKER(TM), DESKTOP MODEL, a class II device, cleared for Qualitone Hearing Aids and Audiometers on under FDA product code EWO (Audiometer). FDA records list one 510(k) clearance for Qualitone Hearing Aids and Audiometers. As of , FDA records show no recalls naming K904622.

Clearance record

Decision date
Received
(341 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Qualitone Hearing Aids and Audiometers 4931 W. 35th St., Minneapolis MN
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