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FDA 510(k), K191370, DreaMed Advisor Pro
FDA 510(k), K191370, DreaMed Advisor Pro
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510(K) Number: K191370
Device Name: DreaMed Advisor Pro
Manufacturer: Eran Atlas
Device Classification Name: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Regulation Number: QCC
Classification Product Code: KXA
Date Received: 05/22/2019
Decision Date: 07/18/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: DreaMed Advisor Pro
Manufacturer: Eran Atlas
Device Classification Name: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Regulation Number: QCC
Classification Product Code: KXA
Date Received: 05/22/2019
Decision Date: 07/18/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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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. Learn more about Fast-Track Requests here.
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