CoPilot Health Management System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062770 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 CoPilot Health Management System is a software application designed to help users manage diabetes by uploading recorded test results from supported Abbott Diabetes Care blood glucose monitoring systems. It allows users to record information about insulin, ketones, medications, meals, exercise, state of health, medical exams, lab results, and general notes.
The system is a PC-based software application that is compatible with Abbott Diabetes Care blood glucose monitoring systems. It is designed to help users and their healthcare providers review and evaluate key information, test results, and trends. The device has received FDA 510(k) clearance with the product code NBW and was determined to be substantially equivalent.
Frequently asked questions
What is the CoPilot Health Management System used for?
The CoPilot Health Management System is a PC-based software application designed to help users manage diabetes by uploading recorded test results from supported Abbott Diabetes Care blood glucose monitoring systems. It allows tracking of insulin, ketones, medications, meals, exercise, and other health data.
How is the CoPilot Health Management System supplied?
The system is supplied as a PC-based software application that is compatible with Abbott Diabetes Care blood glucose monitoring systems. Users can upload their test results and other health information to the software for review and evaluation.
What regulatory approval has the CoPilot Health Management System received?
The CoPilot Health Management System has received FDA 510(k) clearance with the product code NBW and was determined to be substantially equivalent. It was reviewed by the Clinical Chemistry advisory committee.
What information can be recorded in the CoPilot Health Management System?
Users can record comprehensive information including insulin levels, ketones, medications, meals, exercise, state of health, medical exams, lab results, and general notes. This data helps users and healthcare providers review and evaluate key information and trends.
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: Abbott 4.2 CoPilot Health Management System User's Guide, Helping people manage diabetes with more confidence, Diabetes management software FreeStyle CoPilot Abbott Diabetes Care
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062770 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K062770 24 fields · synced Sep 22, 2026