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FDA 510(k), K191679, Omnipod DASH Insulin Management System with interoperable technology
FDA 510(k), K191679, Omnipod DASH Insulin Management System with interoperable technology
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510(K) Number: K191679
Device Name: Omnipod DASH Insulin Management System with interoperable technology
Manufacturer: Julie Perkins
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: QFG
Classification Product Code: 06/24/2019
Date Received: 09/20/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: Omnipod DASH Insulin Management System with interoperable technology
Manufacturer: Julie Perkins
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: QFG
Classification Product Code: 06/24/2019
Date Received: 09/20/2019
Decision Date: Substantially Equivalent (SESE)
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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