The following data is part of a premarket notification filed by Zyno Medical Llc with the FDA for Zyno Z-800 Infusion System Model Z-800.
| Device ID | K100705 |
| 510k Number | K100705 |
| Device Name: | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 |
| Classification | Pump, Infusion |
| Applicant | ZYNO MEDICAL LLC 395 TOTTEN POND RD. SUITE 201 Waltham, MA 02451 |
| Contact | Chaoyoung Lee |
| Correspondent | Chaoyoung Lee ZYNO MEDICAL LLC 395 TOTTEN POND RD. SUITE 201 Waltham, MA 02451 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2010-07-08 |
| Summary: | summary |