Ascensia Contour Blood Glucose Meter, Model 7151 +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062058 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
- Models / Variants
- Reagent Strip, Model 7080 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ascensia Contour Blood Glucose Meter, Model 7151, is a blood glucose monitoring system designed for the self-testing of glucose concentrations in whole blood. It features a clear display and three buttons to facilitate the measurement process when used with the Reagent Strip, Model 7080.
This system is supplied for use in monitoring blood glucose levels. It has received FDA 510k clearance under the clinical chemistry advisory committee.
Frequently asked questions
What is the primary purpose of the Ascensia Contour Model 7151?
The Ascensia Contour Model 7151 is a blood glucose monitoring system designed for self-testing glucose concentrations in whole blood. It is intended for individuals who need to monitor their blood glucose levels regularly.
Which reagent strips are compatible with this blood glucose meter?
The system is designed to be used specifically with the Reagent Strip, Model 7080, to facilitate the measurement process and provide accurate glucose concentration readings.
What is the regulatory status of the Ascensia Contour system?
The Ascensia Contour Blood Glucose Meter, Model 7151, has received FDA 510k clearance under the clinical chemistry advisory committee, confirming it has been determined to be substantially equivalent to existing devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BAYER HEALTHCARE ASCENSIA CONTOUR USER MANUAL Pdf Download, Bayer HealthCare Ascensia Contour Blood Glucose Meter User Manual, Ascensia Contour Blood Glucose Monitoring System, BAYER HEALTHCARE ASCENSIA CONTOUR USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062058 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer Healthcare
Sources (1)
- FDA 510(k) K062058 24 fields · synced Oct 6, 2026