FDA 510(k), K162613, Integrated Catch-up Freedom Syringe Driver Infusion System
FDA 510(k), K162613, Integrated Catch-up Freedom Syringe Driver Infusion System
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510(K) Number: K162613
Device Name: Integrated Catch-up Freedom Syringe Driver Infusion System
Manufacturer: Fred Ma
Device Classification Name: Pump, Infusion
Regulation Number: FRN
Classification Product Code: 09/19/2016
Date Received: 08/31/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Integrated Catch-up Freedom Syringe Driver Infusion System
Manufacturer: Fred Ma
Device Classification Name: Pump, Infusion
Regulation Number: FRN
Classification Product Code: 09/19/2016
Date Received: 08/31/2017
Decision Date: Substantially Equivalent (SESE)
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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