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510(k) K141213

AMERIWATER OZONE DISINFECTION SYSTEM by Ameriwater — Product Code FIN

K141213 is an FDA 510(k) premarket notification submitted by Ameriwater for the device "AMERIWATER OZONE DISINFECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 10, 2014. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820. Ameriwater has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2014
Date Received
May 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tank, Holding, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Ameriwater

  • K223656 — AmeriWater MediQA Reverse Osmosis System (MSP3HF) (February 13, 2023)
  • K142285 — AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz (December 1, 2014)
  • K133783 — AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION (April 16, 2014)
  • K131904 — MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE (November 13, 2013)
  • K131622 — MROZ REVERSE OSMOSIS SYSTEM (September 20, 2013)
  • K121022 — AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCT (September 17, 2012)
  • K111740 — AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION (October 5, 2011)
  • K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (January 6, 2006)
  • K021560 — MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (August 14, 2003)
  • K030059 — PORTABLE RO+ MODEL MROS09 (April 7, 2003)

Other clearances for product code FIN

  • K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (January 12, 2015)
  • K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM (January 26, 2012)
  • K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (December 8, 2010)
  • K060333 — DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM (September 8, 2006)
  • K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (January 6, 2006)
  • K031502 — USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (August 27, 2004)
  • K033118 — BIPRO MODEL SDS-CB200 (June 28, 2004)
  • K030366 — BICARD MIXING SYSTEM (April 19, 2004)
  • K023011 — OSMONICS SOLUTION DELIVERY SYSTEM (June 26, 2003)
  • K003560 — MAR COR SERVICES BICARB SYSTEM (June 8, 2001)

FDA data resources