FDA 510(k), K180045, Omnipod DASH Insulin Management System
FDA 510(k), K180045, Omnipod DASH Insulin Management System
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510(K) Number: K180045
Device Name: Omnipod DASH Insulin Management System
Manufacturer: Insulet Corporation
Device Classification Name: pump, infusion, insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 01/08/2018
Decision Date: 06/01/2018
Regulation Medical Specialty: General Hospital
Device Name: Omnipod DASH Insulin Management System
Manufacturer: Insulet Corporation
Device Classification Name: pump, infusion, insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 01/08/2018
Decision Date: 06/01/2018
Regulation Medical Specialty: General Hospital
- 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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