BIO-LOGIC INSERT EARPHONES— 510(k) K031352

Substantially Equivalent

Bio-Logic Systems Corp.

FDA 510(k) clearance K031352 for BIO-LOGIC INSERT EARPHONES, Substantially Equivalent on 2003-07-16. Applicant: Bio-Logic Systems Corp..

Clearance details

Applicant: Bio-Logic Systems Corp.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2003-04-29
Decision date: 2003-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mudelein, IL, US

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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.