SODEM HIGH SPEED SYSTEM (PNEUMATIC)— 510(k) K023070

Substantially Equivalent

Sodemsystems

FDA 510(k) clearance K023070 for SODEM HIGH SPEED SYSTEM (PNEUMATIC), Substantially Equivalent on 2003-01-28. Applicant: Sodemsystems.

Clearance details

Applicant: Sodemsystems
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2002-09-16
Decision date: 2003-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

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.