AquaC UNO H
FDA 510(k) clearance K143617 · decided 2015-10-19
Clearance details
- K-number
- K143617
- Device name
- AquaC UNO H
- Applicant
- Vivonic GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-12-19
- Decision date
- 2015-10-19
- Days to decision
- 304 days
- Clearance type
- Traditional
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sailauf, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemod recall (Z-2141-2024) | Fresenius Medical Care Holdings, Inc. | 2024-06-13 |
| AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with recall (Z-1769-2022) | Fresenius Medical Care Holdings, Inc. | 2022-09-19 |
| AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with recall (Z-1770-2022) | Fresenius Medical Care Holdings, Inc. | 2022-09-19 |
| AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G020 recall (Z-1463-2022) | Fresenius Medical Care Holdings, Inc. | 2022-07-25 |
| AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G020 recall (Z-1464-2022) | Fresenius Medical Care Holdings, Inc. | 2022-07-25 |