Known Identifiers & Locations
FEI Numbers
1000515504
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0004-05 |
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
Reason: The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.
|
2004-09-03 |
Terminated
|
View Details
|
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