510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K974501Substantially Equivalent

Digital Tinnitus Masking System

Petroff Audio Technologies, West Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974501 is the FDA 510(k) clearance record for DIGITAL TINNITUS MASKING SYSTEM, a class II device, cleared for Petroff Audio Technologies on under FDA product code KLW (Masker, Tinnitus). FDA records list one 510(k) clearance for Petroff Audio Technologies. As of , FDA records show no recalls naming K974501.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Petroff Audio Technologies 6520 Platt Ave., #813, West Hills CA
510(k) summary
Statement
Third party review
No

Clearances, product code KLW

Trailing 12 months
2 clearances under product code KLW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260