The following data is part of a premarket notification filed by Zyno Medical Llc. with the FDA for Halo Ambulatory Infusion System.
| Device ID | K140783 |
| 510k Number | K140783 |
| Device Name: | HALO 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 | 2014-03-31 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40817170020046 | K140783 | 000 |