AMPLAID A315 AND A319— 510(k) K983915

Name: FDA 510(k) clearance K983915
Creator: U.S. Food and Drug Administration
Published: 1999-01-29

Substantially Equivalent

Amplifon S.P.A.

FDA 510(k) clearance K983915 for AMPLAID A315 AND A319, Substantially Equivalent on 1999-01-29. Applicant: Amplifon S.P.A.. Device class: 2.

Clearance details

Applicant: Amplifon S.P.A.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1998-11-04
Decision date: 1999-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amplifon S.P.A.

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K992370 — AMPLAID A724 AND A7281999-09-20
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K971740 — AMPLAID MK121998-03-16
K974235 — AMPLAID AM501998-02-10
K972959 — AMPLAID MK221998-02-06

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.