510(k) K143617 ยท FIP Subsystem, Water Purification
AquaC UNO H
| Applicant | Vivonic GmbH, Sailauf, DE |
| Decision | Substantially Equivalent, Oct 19, 2015 |
| Received | Dec 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143617
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2024 | Fresenius Medical Care Holdings, Inc. US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis
Vivonic Part Numbers: G02020110
Fresenius Part Number: 24-090A-1 Open, Classified |
FIP | None listed |
| Sep 19, 2022 | Fresenius Medical Care Holdings, Inc. AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems.
Fresenius Part Number: 24-10VA-1
Vivonic Part Number: G02000970-US Open, Classified |
FIP | None listed |
| Sep 19, 2022 | Fresenius Medical Care Holdings, Inc. AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems.
Fresenius Part Number: 24-0970-1
Vivonic Part Number: G02000966-US Open, Classified |
FIP | None listed |
| Jul 25, 2022 | Fresenius Medical Care Holdings, Inc. AquaC UNO H [120V, 60Hz, 1700VA,
Fresenius US-Version: 24-0970-1
Vivonic Part Number: G02000966-US Open, Classified |
FIP | None listed |
| Jul 25, 2022 | Fresenius Medical Care Holdings, Inc. AquaC UNO H [120V, 60Hz, 1000VA,
Fresenius US-Version: 24-10VA-1
Vivonic Part Number: G02000970-US Open, Classified |
FIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.