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
K973377Substantially Equivalent

Sibelmed Ac50d

Trutone, Tulsa OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973377 is the FDA 510(k) clearance record for SIBELMED AC50D, a class II device, cleared for Trutone on under FDA product code EWO (Audiometer). FDA records list 5 510(k) clearances for Trutone, from to . As of , FDA records show no recalls naming K973377.

Clearance record

Decision date
Received
(183 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Trutone 3113 S. 115th E. Ave., Tulsa OK
510(k) summary
Statement
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