Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
FDA 510(k) K153193 · Zyno Medical, LLC
510(k) numberK153193
Submission
- Device name
- Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
- Applicant
- Zyno Medical, LLC
Natick, MA, US - Received
- November 3, 2015
- Decision date
- August 30, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K140783 | Halo Ambulatory Infusion SystemFRN · Abbreviated | 10/17/2014SE |
| K132841 | Zyno Medical Administration SetFPA · Special | 01/23/2014SE |
| K130690 | Z-800 Infusion SystemFRN · Special | 06/12/2013SE |
| K120685 | Zyno Medical Administration SetFPA · Abbreviated | 09/07/2012SE |
| K100705 | Zyno Z-800 Infusion System Model Z-800FRN · Abbreviated | 07/08/2010SE |
| K071545 | Z-800 Volumetric Infusion PumpFRN · Traditional | 10/31/2007SE |
Questions and answers
When was Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) cleared by the FDA?
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (K153193) received a 510(k) decision of Substantially Equivalent on August 30, 2016, 301 days after the submission was received.
What is the product code of K153193?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.