EPITOME SYSTEM— 510(k) K041206

Substantially Equivalent

Gebauer Medizintechnik GmbH

FDA 510(k) clearance K041206 for EPITOME SYSTEM, Substantially Equivalent on 2004-09-15. Applicant: Gebauer Medizintechnik GmbH.

Clearance details

Applicant: Gebauer Medizintechnik GmbH
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2004-05-07
Decision date: 2004-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.