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510(k) K153193

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) by Zyno Medical, LLC — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2016
Date Received
November 3, 2015
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Zyno Medical, LLC

  • K140783 — HALO AMBULATORY INFUSION SYSTEM (October 17, 2014)
  • K132841 — ZYNO MEDICAL ADMINISTRATION SET (January 23, 2014)
  • K130690 — Z-800 INFUSION SYSTEM (June 12, 2013)
  • K120685 — ZYNO MEDICAL ADMINISTRATION SET (September 7, 2012)
  • K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (July 8, 2010)
  • K071545 — Z-800 VOLUMETRIC INFUSION PUMP (October 31, 2007)

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