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

Name: FDA 510(k) clearance K092111
Creator: U.S. Food and Drug Administration
Published: 2009-10-02

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. Device class: 2.

Clearance details

Applicant: Entomed AB
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
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 ↗

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K191372 — Lyra2019-07-15

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.