The following data is part of a premarket notification filed by Zyno Medical Llc with the FDA for Halo Ii Ambulatory Infusion System (also With Trade Names Nimbus Ii Ambulatory Infusion System, Evaa Ambulatory Infusion System).
| Device ID | K153193 |
| 510k Number | K153193 |
| Device Name: | Halo II Ambulatory Infusion System (also With Trade Names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) |
| Classification | Pump, Infusion |
| Applicant | ZYNO MEDICAL LLC 177 PINE ST Natick, MA 01760 |
| Contact | Mei Zhang |
| Correspondent | Mei Zhang ZYNO MEDICAL LLC 177 PINE ST Natick, MA 01760 |
| Product Code | FRN |
| Subsequent Product Code | FPA |
| Subsequent Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2016-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817170020154 | K153193 | 000 |
| 10817170020106 | K153193 | 000 |
| 10817170020090 | K153193 | 000 |
| 10817170020083 | K153193 | 000 |
| 20817170020165 | K153193 | 000 |
| 00817170020376 | K153193 | 000 |