ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204— 510(k) K092111

Substantially Equivalent

Entomed AB

FDA 510(k) clearance K092111 for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204, Substantially Equivalent on 2009-10-02. Applicant: Entomed AB.

Clearance details

Applicant: Entomed AB
Product code: 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

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.