ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)— 510(k) K980533

Substantially Equivalent

Etymotic Research

FDA 510(k) clearance K980533 for ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34), Substantially Equivalent on 1998-03-23. Applicant: Etymotic Research.

Clearance details

Applicant: Etymotic Research
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1998-02-11
Decision date: 1998-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, 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.