SIBELMED AC50D— 510(k) K973377

Substantially Equivalent

Trutone

FDA 510(k) clearance K973377 for SIBELMED AC50D, Substantially Equivalent on 1998-03-10. Applicant: Trutone.

Clearance details

Applicant: Trutone
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1997-09-08
Decision date: 1998-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, 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.