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FDA 510(k), K153193, Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
FDA 510(k), K153193, Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
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$149.00 USD
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510(K) Number: K153193
Device Name: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
Manufacturer: ZYNO MEDICAL LLC
Device Classification Name: Pump, Infusion
Regulation Number: 880.5725
Classification Product Code: FRN
Date Received: 11/03/2015
Decision Date: 08/30/2016
Regulation Medical Specialty: General Hospital
Device Name: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
Manufacturer: ZYNO MEDICAL LLC
Device Classification Name: Pump, Infusion
Regulation Number: 880.5725
Classification Product Code: FRN
Date Received: 11/03/2015
Decision Date: 08/30/2016
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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