FINN CHAMBER (R)— 510(k) K013820

Name: FDA 510(k) clearance K013820
Creator: U.S. Food and Drug Administration
Published: 2002-01-30

Substantially Equivalent

Epitest Ltd. OY

FDA 510(k) clearance K013820 for FINN CHAMBER (R), Substantially Equivalent on 2002-01-30. Applicant: Epitest Ltd. OY. Device class: 1.

Clearance details

Applicant: Epitest Ltd. OY
Product code: Code KXF
Device class: Class 1
Regulation: 21 CFR 880.6025
Advisory panel: General Hospital
Date received: 2001-11-16
Decision date: 2002-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaluma, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXF

view all

K123184 — FINN CHAMBERS AQUA2012-12-19
K103409 — ALLERGEAZE R CLEAR2011-03-15
K063160 — ALLERGEAZE PATCH TEST CHAMBERS2006-12-22
K992553 — IQ CHAMBERS2000-04-12
K870762 — EAR APPLICATOR, CATALOG NO. 22291987-03-06

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.