EasyMax BT Self-Monitoring Blood Glucose System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182057 FDA 510(k)
- FDA Product Code
- NBW 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 EasyMax BT Self-Monitoring Blood Glucose System is a device intended for the quantitative measurement of glucose in fresh venous blood and capillary whole blood samples. It is designed to test samples drawn from the fingertip, palm, or forearm.
This system is intended for single patient home use. It has received FDA 510k clearance under K182057. Users should refer to the provided user manual for operation instructions.
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: PDF Microsoft Word - I-D-I0110A_(71800561A)_01_EasyMax BT UM E_FDA_070418.doc, EasyMax BT Self-Monitoring Blood Glucose System, EPS Bio Technology EASYMAX sugarwatch User Manual, I-D-I0110A (71800561A) 01 EasyMax BT UM E FDA 070418 - Manuals+
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182057 | Class II | Active |
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Manufacturer
- Manufacturer
- Eps Bio Technology Corp.
Sources (1)
- FDA 510(k) K182057 24 fields · synced Sep 26, 2026