AUTOMATIC SCREENING AUDIOMETER— 510(k) K810537

Substantially Equivalent

Positron

FDA 510(k) clearance K810537 for AUTOMATIC SCREENING AUDIOMETER, Substantially Equivalent on 1981-03-11. Applicant: Positron.

Clearance details

Applicant: Positron
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1981-02-26
Decision date: 1981-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.