510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970974Substantially Equivalent

Williams Sound, Personal Fm System, Hearing Helper

Williams Sound, LLC, Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970974 is the FDA 510(k) clearance record for WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER, a class II device, cleared for Williams Sound, LLC on under FDA product code LZI (Device, Assistive Listening). FDA records list 4 510(k) clearances for Williams Sound, LLC, from to . As of , FDA records show no recalls naming K970974.

Clearance record

Decision date
Received
(46 days to decision)
Product code
LZI Device, Assistive Listening
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Williams Sound, LLC 10300 Valley View Rd., Eden Prairie MN
510(k) summary
Statement
Third party review
No

Clearances, product code LZI

Trailing 12 months

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

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