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FDA 510(k), K163357, OneTouch Via On-Demand Insulin Delivery System
FDA 510(k), K163357, OneTouch Via On-Demand Insulin Delivery System
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510(K) Number: K163357
Device Name: OneTouch Via On-Demand Insulin Delivery System
Manufacturer: LifeScan Europe, a division of Cilag GmbH
Device Classification Name: pump, infusion, insulin bolus
Regulation Number: 880.5725
Classification Product Code: OPP
Date Received: 11/30/2016
Decision Date: 06/07/2017
Regulation Medical Specialty: General Hospital
Device Name: OneTouch Via On-Demand Insulin Delivery System
Manufacturer: LifeScan Europe, a division of Cilag GmbH
Device Classification Name: pump, infusion, insulin bolus
Regulation Number: 880.5725
Classification Product Code: OPP
Date Received: 11/30/2016
Decision Date: 06/07/2017
Regulation Medical Specialty: General Hospital
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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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