ACCU-CHEK CONNECT DIABETES MANAGEMENT APP— 510(k) K141929
Substantially EquivalentRoche Diagnostics Corporation
FDA 510(k) clearance K141929 for ACCU-CHEK CONNECT DIABETES MANAGEMENT APP, Substantially Equivalent on 2015-03-16. Applicant: Roche Diagnostics Corporation.
Clearance details
- Applicant
- Roche Diagnostics Corporation
- Product code
- Code NDC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Adverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
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.