ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K141867

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K141867 for ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2015-03-03. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2014-07-10
Decision date: 2015-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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.