The following data is part of a premarket notification filed by Vivonic Gmbh with the FDA for Aquabplus,aquabplus & Aquabplus B2,aquabplus&aquabplus Hf,aquabplus& Aquabplus B2& Aquablus Hf.
| Device ID | K133829 |
| 510k Number | K133829 |
| Device Name: | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF |
| 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 | 2013-12-17 |
| Decision Date | 2014-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251285200296 | K133829 | 000 |
| 04251285200135 | K133829 | 000 |
| 04251285200128 | K133829 | 000 |
| 04251285200111 | K133829 | 000 |
| 04251285200104 | K133829 | 000 |
| 04251285200098 | K133829 | 000 |
| 04251285200081 | K133829 | 000 |
| 04251285200074 | K133829 | 000 |
| 04251285200067 | K133829 | 000 |
| 04251285200050 | K133829 | 000 |
| 04251285200043 | K133829 | 000 |
| 04251285200036 | K133829 | 000 |
| 04251285200029 | K133829 | 000 |
| 04251285200142 | K133829 | 000 |
| 04251285200159 | K133829 | 000 |
| 04251285200289 | K133829 | 000 |
| 04251285200272 | K133829 | 000 |
| 04251285200265 | K133829 | 000 |
| 04251285200258 | K133829 | 000 |
| 04251285200241 | K133829 | 000 |
| 04251285200227 | K133829 | 000 |
| 04251285200210 | K133829 | 000 |
| 04251285200203 | K133829 | 000 |
| 04251285200197 | K133829 | 000 |
| 04251285200180 | K133829 | 000 |
| 04251285200173 | K133829 | 000 |
| 04251285200166 | K133829 | 000 |
| 04251285200012 | K133829 | 000 |