510(k) K092481
- Device
- HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
- Applicant
- NEW AQUA LLC (DBA AQUA SYSTEMS)
- 510(k) number
- K092481
- Product code
- FIP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-04-02
- Date received
- 2009-08-13
- Regulation
- 876.5665
- Classification name
- Subsystem, Water Purification
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NEVIN RUDIE
- Address
- 114 Vista Pkwy. Avon IN US 46123 46123
FDA Registration Numbers#
- 3005162618
- 3017974963
- 3032828299
- 9611369
- 9611823
- 3007007791
- 3003550196
- 1833387
- 3038195011
- 1225714
- 3019131
- 3005695808
- 3004057358
- 3014144799
- 3006029151
- 3003768032
- 3035708507
- 1651434
- 3003337893
- 3012119281
- 3010867648
- 3010120148
- 3016096143
- 3002807295
- 3015136750
- 8010182
- 3010866895
- 3004188066
- 3043014136
- 3002879653
- 1530185
- 3015349756
- 3010041430
- 3010120135
- 3006426779
- 9611824
- 3013507157
- 1720309
- 1833407
- 1833920
- 3014279513
- 3004111573
- 3010850471
- 3010863450
- 3043543260
- 3009959868
- 3010032903
- 2135346
- 3010178296
- 3010355846
- 3015335038
- 3013764800
- 1055109
- 3005578748
- 8030665
- 3017552925
- 3038138522
- 9615942
- 1651723
Source Documents#
Other 510(k) Records For Product Code FIP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 |
| K252181 | AquaA | Fresenius Medical Care North America | 2025-09-09 |
| K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025-03-17 |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | 2023-08-16 |
| K231410 | RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies, LLC | 2023-07-19 |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | 2023-02-13 |
| K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 |
| K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | 2021-10-19 |
| K200670 | EON Portable RO Water Purification System | Mar Cor Purification, Inc. | 2020-04-16 |
| K192398 | Millenium HX | Mar Cor Purification, Inc. | 2019-10-03 |
| K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 |
| K171099 | EON Portable Reverse Osmosis Water Purification System | Cantel | 2018-01-05 |
| K161304 | EndoPur Filter | Nephros, Inc. | 2017-03-02 |
Legacy Summary#
summary
FDA Review#
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