BIONIME DIABETES MANAGEMENT SYSTEM VI.0— 510(k) K113007
Substantially EquivalentBionime Corporation
FDA 510(k) clearance K113007 for BIONIME DIABETES MANAGEMENT SYSTEM VI.0, Substantially Equivalent on 2012-02-27. Applicant: Bionime Corporation. Device class: 1.
Clearance details
- Applicant
- Bionime Corporation
- Product code
- Code JQP
- Device class
- Class 1
- Regulation
- 21 CFR 862.2100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mission Viejo, CA, US
Recent devices under product code JQP
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view all- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
- K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel
- K221062 — RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
- K190564 — Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
- K173638 — Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
Adverse events under product code JQP
product code JQP- Death
- 3
- Malfunction
- 690
- Total
- 693
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.