Identifiers
- 510(k) Number
- DEN230052 FDA 510(k)
- FDA Product Code
- SBA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1357 FDA 510(k)
- Regulation Number
- 862.1357 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Eversense AP CGM System is an integrated continuous glucose monitoring system. It is designed for the continuous measurement of glucose levels in interstitial fluid.
This device is authorized under FDA 510K. It is categorized as a class 2 medical device under regulation number 862.1357.
Frequently asked questions
What is the primary function of the Eversense AP CGM System?
The Eversense AP CGM System is an integrated continuous glucose monitoring system designed to provide continuous measurement of glucose levels within the interstitial fluid.
What is the regulatory classification of this device?
The Eversense AP CGM System is categorized as a class 2 medical device under regulation number 862.1357 and is authorized under FDA 510K.
Who is the manufacturer of the Eversense AP CGM System?
The device is manufactured by Senseonics, Incorporated, located in Germantown, Maryland.
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: Das Eversense Glucose Monitoring (CGM) Diabetes System fürs …, Eversense Continuous Glucose Monitoring (CGM) Device | Glucose ..., Eversense CGM System | Long-Term Implantable CGM | Global, Eversense: Ein Langzeit-CGM für Diabetiker - GlucoseCode, Kurzanleitung - Eversense CGM System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN230052 | Class II | Active |
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Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA 510(k) DEN230052 24 fields · synced Sep 23, 2026