AquaC UNO H— 510(k) K143617
Substantially EquivalentVivonic GmbH
FDA 510(k) clearance K143617 for AquaC UNO H, Substantially Equivalent on 2015-10-19. Applicant: Vivonic GmbH. Device class: 2.
Clearance details
- Applicant
- Vivonic GmbH
- Product code
- Code FIP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sailauf, DE
Recent devices under product code FIP
view allMore clearances from Vivonic GmbH
view allAdverse events under product code FIP
product code FIP- Malfunction
- 490
- Total
- 490
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K143617
K-number listed on FDA's recall record- Z-2141-2024 — 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
- Z-1769-2022 — 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
- Z-1770-2022 — 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
- Z-1463-2022 — AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
- Z-1464-2022 — AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143617.
Data sourced from openFDA. This site is unofficial and independent of the FDA.