510(k) K133829 ยท FIP Subsystem, Water Purification
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
| Applicant | Vivonic GmbH, Sailauf, DE |
| Decision | Substantially Equivalent, Apr 22, 2014 |
| Received | Dec 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2021 | Fresenius Medical Care Holdings, Inc. AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US) Terminated |
FIP | None listed |
| Mar 18, 2021 | Fresenius Medical Care Holdings, Inc. AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water u Terminated |
FIP | None listed |
| Sep 1, 2020 | Fresenius Medical Care Holdings, Inc. AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or Terminated |
FIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.