Contour Next EZ Blood Glucose Monitoring System— 510(k) K162336
Substantially EquivalentAscensia Diabetes Care U.S., Inc.
FDA 510(k) clearance K162336 for Contour Next EZ Blood Glucose Monitoring System, Substantially Equivalent on 2017-01-12. Applicant: Ascensia Diabetes Care U.S., Inc.. Device class: 2.
Clearance details
- Applicant
- Ascensia Diabetes Care U.S., Inc.
- Product code
- 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
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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.