The following data is part of a premarket notification filed by Vivonic Gmbh with the FDA for Aquac Uno H.
| Device ID | K143617 |
| 510k Number | K143617 |
| Device Name: | AquaC UNO H |
| Classification | Subsystem, Water Purification |
| Applicant | VIVONIC GMBH KURFUERST-EPPSTEIN-RING 4 Sailauf, DE 63877 |
| Contact | Andreas Hessberger |
| Correspondent | Andreas Hessberger VIVONIC GMBH KURFUERST-EPPSTEIN-RING 4 Sailauf, DE 63877 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-19 |
| Decision Date | 2015-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251285200234 | K143617 | 000 |