SMARTTROAE— 510(k) K023859

Substantially Equivalent

Intelligent Hearing Systems

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

Clearance details

Applicant: Intelligent Hearing Systems
Product code: Code EWO
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 ↗

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.