FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K Number: K051031
·
Decision Jan 6, 2006
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
17
Applicant Total
11
Review Days
259
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Basic Information
- Device Name
- AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
- K Number
- K051031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ameriwater
- Date Received
- April 22, 2005
- Decision Date
- January 6, 2006
- Product Code
- FIN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIN | Tank, Holding, Dialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIN), ordered by most recent decision date.
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
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AMERIWATER OZONE DISINFECTION SYSTEM
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BICARB MIXING AND DISTRIBUTION SYSTEM
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TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
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DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Ameriwater
| K Number | Device Name | ||
|---|---|---|---|
| K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | Dec 10, 2014 | Substantially Equivalent |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | Dec 1, 2014 | Substantially Equivalent |
| K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | Apr 16, 2014 | Substantially Equivalent |
| K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA | Nov 13, 2013 | Substantially Equivalent |
| K131622 | MROZ REVERSE OSMOSIS SYSTEM | Sep 20, 2013 | Substantially Equivalent |
| K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV | Sep 17, 2012 | Substantially Equivalent |
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | Oct 5, 2011 | Substantially Equivalent |
| K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Aug 14, 2003 | Substantially Equivalent |
| K030059 | PORTABLE RO+ MODEL MROS09 | Apr 7, 2003 | Substantially Equivalent |
| K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Apr 14, 2000 | Substantially Equivalent |