510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880259Substantially Equivalent

Visual Reinforce. Audio Cassette Unit: Basic & Adv

Colorado Hearing Systems, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880259 is the FDA 510(k) clearance record for VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV, a class II device, cleared for Colorado Hearing Systems, Inc. on under FDA product code LYN (Apparatus, Visual Reinforcement Audiometric). FDA records list one 510(k) clearance for Colorado Hearing Systems, Inc. As of , FDA records show no recalls naming K880259.

Clearance record

Decision date
Received
(437 days to decision)
Product code
LYN Apparatus, Visual Reinforcement Audiometric
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Colorado Hearing Systems, Inc. P.O. Box 20324, Denver CO
Third party review
No

Clearances, product code LYN

Trailing 12 months

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

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