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FDA 510(k), K210561, Advisor Pro Platform
FDA 510(k), K210561, Advisor Pro Platform
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510(K) Number: K210561
Device Name: Advisor Pro Platform
Manufacturer: DreaMed Diabetes Ltd.
Device Classification Name: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Regulation Number: 862.1358
Classification Product Code: QCC
Date Received: 02/25/2021
Decision Date: 09/28/2021
Regulation Medical Specialty: Clinical Chemistry
Device Name: Advisor Pro Platform
Manufacturer: DreaMed Diabetes Ltd.
Device Classification Name: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Regulation Number: 862.1358
Classification Product Code: QCC
Date Received: 02/25/2021
Decision Date: 09/28/2021
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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