THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER— 510(k) K900197

Name: FDA 510(k) clearance K900197
Creator: U.S. Food and Drug Administration
Published: 1991-04-17

Substantially Equivalent

Sound Linked Data, Inc.

FDA 510(k) clearance K900197 for THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER, Substantially Equivalent on 1991-04-17. Applicant: Sound Linked Data, Inc.. Device class: 2.

Clearance details

Applicant: Sound Linked Data, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1990-01-16
Decision date: 1991-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada L4w 2tf, CA

Download summary PDF View on FDA.gov ↗

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K234095 — OtoNova/OtoNova Pro2024-06-21
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K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2022-06-22
K191372 — Lyra2019-07-15

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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