FINN CHAMBER (R)— 510(k) K013820

Substantially Equivalent

Epitest Ltd. OY

FDA 510(k) clearance K013820 for FINN CHAMBER (R), Substantially Equivalent on 2002-01-30. Applicant: Epitest Ltd. OY.

Clearance details

Applicant: Epitest Ltd. OY
Product code: Code KXF
Advisory panel: General Hospital
Date received: 2001-11-16
Decision date: 2002-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaluma, CA, US

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Adverse events under product code KXF

product code KXF

Other: 1
Total: 1

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.