AMPLAID 460— 510(k) K971747

Substantially Equivalent

Amplifon S.P.A.

FDA 510(k) clearance K971747 for AMPLAID 460, Substantially Equivalent on 1997-08-05. Applicant: Amplifon S.P.A..

Clearance details

Applicant: Amplifon S.P.A.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1997-05-12
Decision date: 1997-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, 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.