SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)— 510(k) K012456

Substantially Equivalent

Sodemsystems

FDA 510(k) clearance K012456 for SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT), Substantially Equivalent on 2001-09-21. Applicant: Sodemsystems.

Clearance details

Applicant: Sodemsystems
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2001-08-01
Decision date: 2001-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

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Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.