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510(k) K140984

TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM by Tango3, LLC — Product Code FIN

K140984 is an FDA 510(k) premarket notification submitted by Tango3, LLC for the device "TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 2015. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820. Tango3, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2015
Date Received
April 16, 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 Tango3, LLC

  • K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (December 8, 2010)

Other clearances for product code FIN

  • 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)
  • K003560 — MAR COR SERVICES BICARB SYSTEM (June 8, 2001)

FDA data resources