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510(k) K992793

SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM by Better Water, Inc. — Product Code FIN

K992793 is an FDA 510(k) premarket notification submitted by Better Water, Inc. for the device "SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 16, 1999. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820. Better Water, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1999
Date Received
August 19, 1999
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 Better Water, Inc.

  • K161844 — Matrix Pre-Treatment Controller (December 13, 2016)
  • K051620 — MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES (November 18, 2005)
  • K954928 — PORTABLE REVERSE OSMOSIS MACHINE (January 24, 1996)
  • K920186 — WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (June 13, 1995)

Other clearances for product code FIN

  • K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (January 12, 2015)
  • K141213 — AMERIWATER OZONE DISINFECTION SYSTEM (December 10, 2014)
  • 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)

FDA data resources