The following data is part of a premarket notification filed by Zyno Medical Llc with the FDA for Z-800 Infusion System.
| Device ID | K130690 |
| 510k Number | K130690 |
| Device Name: | Z-800 INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | ZYNO MEDICAL LLC 177 PINE ST Natick, MA 01760 |
| Contact | Mei Zhang Phd |
| Correspondent | Mei Zhang Phd ZYNO MEDICAL LLC 177 PINE ST Natick, MA 01760 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-14 |
| Decision Date | 2013-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814371020031 | K130690 | 000 |
| 20814371020024 | K130690 | 000 |
| 20814371020017 | K130690 | 000 |
| 00814371020006 | K130690 | 000 |