RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K062567
Substantially EquivalentBionime Corporation
FDA 510(k) clearance K062567 for RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2007-02-16. Applicant: Bionime Corporation. Device class: 2.
Clearance details
- Applicant
- Bionime Corporation
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Recent devices under product code NBW
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- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
More clearances from Bionime Corporation
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 NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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.