AMPLAID MK12— 510(k) K971740

Name: FDA 510(k) clearance K971740
Creator: U.S. Food and Drug Administration
Published: 1998-03-16

Substantially Equivalent

Amplifon S.P.A.

FDA 510(k) clearance K971740 for AMPLAID MK12, Substantially Equivalent on 1998-03-16. Applicant: Amplifon S.P.A.. Device class: 2.

Clearance details

Applicant: Amplifon S.P.A.
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 1997-05-12
Decision date: 1998-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.