SMARTTROAE— 510(k) K023859

Name: FDA 510(k) clearance K023859
Creator: U.S. Food and Drug Administration
Published: 2003-01-08

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K023859 for SMARTTROAE, Substantially Equivalent on 2003-01-08. Applicant: Intelligent Hearing Systems. Device class: 2.

Clearance details

Applicant: Intelligent Hearing Systems
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 2002-11-20
Decision date: 2003-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K234095 — OtoNova/OtoNova Pro2024-06-21
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K231545 — hearOAE2023-10-27
K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2022-06-22
K191372 — Lyra2019-07-15

More clearances from Intelligent Hearing Systems

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K163326 — SmartEP2017-09-29
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K073384 — SMART COUPLER, MODEL M0154012008-02-28
K070608 — SMARTEP, MODEL M0100002007-07-18
K063402 — WICK ELECTRODE, MODEL M0192602006-12-11

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.