VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV— 510(k) K880259

Name: FDA 510(k) clearance K880259
Creator: U.S. Food and Drug Administration
Published: 1989-04-03

Substantially Equivalent

Colorado Hearing Systems, Inc.

FDA 510(k) clearance K880259 for VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV, Substantially Equivalent on 1989-04-03. Applicant: Colorado Hearing Systems, Inc.. Device class: 2.

Clearance details

Applicant: Colorado Hearing Systems, Inc.
Product code: Code LYN
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1988-01-22
Decision date: 1989-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYN

view all

K950995 — SENSICARE SYNTHETIC, SURGICAL GLOVE LINER1995-06-28
K897143 — VERA 1031990-04-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.