K092111

Substantially Equivalent

ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204

Applicant: Entomed AB
Product code: EWO
Advisory panel: Ear, Nose, Throat
Date received: 2009-07-14
Decision date: 2009-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malmo, SE

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.