Amia Automated PD System with Sharesource
FDA 510(k) clearance K151525 · decided 2015-10-09
Clearance details
- K-number
- K151525
- Device name
- Amia Automated PD System with Sharesource
- Applicant
- Deka Research and Development
- Decision
- Substantially Equivalent
- Date received
- 2015-06-08
- Decision date
- 2015-10-09
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- FKX
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Manchester, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 recall (Z-0550-2024) | Baxter Healthcare Corporation | 2023-12-14 |