AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON— 510(k) K121793

Substantially Equivalent

Audifon-USA, Inc.

FDA 510(k) clearance K121793 for AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON, Substantially Equivalent on 2012-11-01. Applicant: Audifon-USA, Inc..

Clearance details

Applicant: Audifon-USA, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2012-06-19
Decision date: 2012-11-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Debary, FL, US

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Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

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.