AMIA AUTOMATED PD SYSTEM
FDA 510(k) clearance K124018 · decided 2013-06-14
Clearance details
- K-number
- K124018
- Device name
- AMIA AUTOMATED PD SYSTEM
- Applicant
- Deka Research & Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-27
- Decision date
- 2013-06-14
- Days to decision
- 169 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 PD systems are used in the treatment of adult renal failure patients recall (Z-0932-2015) | Baxter Healthcare Corp. | 2015-01-07 |