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FDA 510(k), K150910, ACCU-CHEK Connect Diabetes Management App
FDA 510(k), K150910, ACCU-CHEK Connect Diabetes Management App
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510(K) Number: K150910
Device Name: ACCU-CHEK Connect Diabetes Management App
Manufacturer: ROCHE DIABETES CARE INC.
Device Classification Name: calculator, drug dose
Regulation Number: 868.1890
Classification Product Code: NDC
Date Received: 04/03/2015
Decision Date: 06/03/2015
Regulation Medical Specialty: Anesthesiology
Device Name: ACCU-CHEK Connect Diabetes Management App
Manufacturer: ROCHE DIABETES CARE INC.
Device Classification Name: calculator, drug dose
Regulation Number: 868.1890
Classification Product Code: NDC
Date Received: 04/03/2015
Decision Date: 06/03/2015
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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