NEURO-AUDIO— 510(k) K141524

Substantially Equivalent

Teleemg, LLC USA

FDA 510(k) clearance K141524 for NEURO-AUDIO, Substantially Equivalent on 2015-03-12. Applicant: Teleemg, LLC USA.

Clearance details

Applicant: Teleemg, LLC USA
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2014-06-09
Decision date: 2015-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salem, NH, 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.