Panels › Gastroenterology, Urology › Product code FIN · Class 2
Tank, Holding, Dialysis
Regulation 876.5820
0510(k)s in 12 months (18 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in FIN
| Company | 510(k)s | Recalls |
|---|---|---|
| Isopure, Corp. | 1 | 2 |
| Tango3, LLC | 2 | 1 |
| Ameriwater | 2 | 0 |
| Pure Water, Inc. | 2 | 0 |
| Better Water, Inc. | 1 | 0 |
| Dial Medical Supply | 1 | 0 |
| Dialysis Services, Inc. | 1 | 0 |
| Dialysis Systems, Inc. | 1 | 0 |
| G.E.M. Water Systems | 1 | 0 |
| Hill-Rom, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2022 | Isopure Corp Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) Open, Classified |
FIN | K112427 |
| Jan 19, 2020 | Isopure Corp Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3 Terminated |
FIN | K112427 |
| Aug 3, 2012 | Tango3 LLC TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Oz Terminated |
FIN | K093641 |
| Jul 24, 2007 | Hill-Rom, Inc. Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006 Terminated |
FIN | None listed |
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