The following data is part of a premarket notification filed by Zyno Medical Llc with the FDA for Z-800 Volumetric Infusion Pump.
| Device ID | K071545 |
| 510k Number | K071545 |
| Device Name: | Z-800 VOLUMETRIC INFUSION PUMP |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-06 |
| Decision Date | 2007-10-31 |
| Summary: | summary |