ALLERGEAZE R CLEAR— 510(k) K103409

Name: FDA 510(k) clearance K103409
Creator: U.S. Food and Drug Administration
Published: 2011-03-15

Substantially Equivalent

Smartpractice

FDA 510(k) clearance K103409 for ALLERGEAZE R CLEAR, Substantially Equivalent on 2011-03-15. Applicant: Smartpractice. Device class: 1.

Clearance details

Applicant: Smartpractice
Product code: Code KXF
Device class: Class 1
Regulation: 21 CFR 880.6025
Advisory panel: General Hospital
Date received: 2010-11-22
Decision date: 2011-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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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.