510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K935348Substantially Equivalent

Odyssey Clinical Audiometer

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

K935348 is the FDA 510(k) clearance record for ODYSSEY CLINICAL AUDIOMETER, a class II device, cleared for Qualitone on under FDA product code EWO (Audiometer). FDA records list 40 510(k) clearances for Qualitone, from to . As of , FDA records show no recalls naming K935348.

Clearance record

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