Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System— 510(k) K160430
Substantially EquivalentAscensia Diabetes Care U.S., Inc.
FDA 510(k) clearance K160430 for Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System, Substantially Equivalent on 2016-06-24. Applicant: Ascensia Diabetes Care U.S., Inc.. Device class: 2.
Clearance details
- Applicant
- Ascensia Diabetes Care U.S., Inc.
- 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
- Special
- Location
- Mishawaka, IN, 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 Ascensia Diabetes Care U.S., Inc.
view allAdverse 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.