Accu-Chek Pocket Compass Diabetes Management Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082595 FDA 510(k)
- FDA Product Code
- LZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accu-Chek Pocket Compass Diabetes Management Software is a device designed for diabetes management. It is a software application that assists in the management of diabetes data.
This software is supplied by Roche Diagnostics and is intended for use in a general hospital setting. It is a modification to the existing Accu-Chek Pocket Compass Diabetes Management Software and has received FDA 510(k) clearance with the device class being 2.
Frequently asked questions
What is the Accu-Chek Pocket Compass Diabetes Management Software?
The Accu-Chek Pocket Compass Diabetes Management Software is a software application designed to assist in the management of diabetes data. It is intended for use in general hospital settings and is a modification to the existing software.
What is the regulatory status of this software?
This software has received FDA 510(k) clearance with a device class of 2. It was determined to be substantially equivalent to existing devices and is classified for use in general hospital settings.
Who manufactures the Accu-Chek Pocket Compass Diabetes Management Software?
The software is manufactured by Roche Diagnostics, a company that specializes in diagnostic and healthcare solutions. The modification to the software was submitted for FDA clearance in 2008.
What is the intended use setting for this software?
The Accu-Chek Pocket Compass Diabetes Management Software is intended for use in a general hospital setting. It is designed to assist healthcare professionals in managing diabetes data effectively.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082595 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K082595 24 fields · synced Sep 28, 2026