510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900197Substantially Equivalent

The Max System, Model: Basic, 1000,2000 Audiometer

Sound Linked Data, Inc., Canada L4w 2tf, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900197 is the FDA 510(k) clearance record for THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER, a class II device, cleared for Sound Linked Data, Inc. on under FDA product code EWO (Audiometer). FDA records list one 510(k) clearance for Sound Linked Data, Inc. As of , FDA records show no recalls naming K900197.

Clearance record

Decision date
Received
(456 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Sound Linked Data, Inc. 5444 Timberlea Blvd., Canada L4w 2tf, CA
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