BIONIME DIABETES MANAGEMENT SYSTEM VI.0— 510(k) K113007

Substantially Equivalent

Bionime Corporation

FDA 510(k) clearance K113007 for BIONIME DIABETES MANAGEMENT SYSTEM VI.0, Substantially Equivalent on 2012-02-27. Applicant: Bionime Corporation.

Clearance details

Applicant: Bionime Corporation
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 2011-10-07
Decision date: 2012-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, US

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.