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FDA 510(k), K191313, Unity Subcutaneous Infusion System for Remodulin
FDA 510(k), K191313, Unity Subcutaneous Infusion System for Remodulin
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$149.00 USD
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$149.00 USD
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510(K) Number: K191313
Device Name: Unity Subcutaneous Infusion System for Remodulin
Manufacturer: DEKA Research & Development
Device Classification Name: infusion pump, drug specific, pharmacy-filled
Regulation Number: 880.5725
Classification Product Code: QJY
Date Received: 05/15/2019
Decision Date: 02/21/2020
Regulation Medical Specialty: General Hospital
Device Name: Unity Subcutaneous Infusion System for Remodulin
Manufacturer: DEKA Research & Development
Device Classification Name: infusion pump, drug specific, pharmacy-filled
Regulation Number: 880.5725
Classification Product Code: QJY
Date Received: 05/15/2019
Decision Date: 02/21/2020
Regulation Medical Specialty: General Hospital
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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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