ACCU-CHEK LINKASSIST— 510(k) K063146
Substantially EquivalentDisetronic Medical Systems AG
FDA 510(k) clearance K063146 for ACCU-CHEK LINKASSIST, Substantially Equivalent on 2006-11-27. Applicant: Disetronic Medical Systems AG.
Clearance details
- Applicant
- Disetronic Medical Systems AG
- Product code
- Code KZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Adverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.