ACCU-CHEK LINKASSIST— 510(k) K063146

Name: FDA 510(k) clearance K063146
Creator: U.S. Food and Drug Administration
Published: 2006-11-27

Substantially Equivalent

Disetronic Medical Systems AG

FDA 510(k) clearance K063146 for ACCU-CHEK LINKASSIST, Substantially Equivalent on 2006-11-27. Applicant: Disetronic Medical Systems AG. Device class: 2.

Clearance details

Applicant: Disetronic Medical Systems AG
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 2006-10-16
Decision date: 2006-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KZH

product code KZH

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.