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510(k) K112427

BICARB MIXING AND DISTRIBUTION SYSTEM by Isopure, Corp. — Product Code FIN

K112427 is an FDA 510(k) premarket notification submitted by Isopure, Corp. for the device "BICARB MIXING AND DISTRIBUTION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 2012. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820. Isopure, Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2012
Date Received
August 23, 2011
Clearance Type
Special
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 Isopure, Corp.

  • K191093 — Isopure Dry Acid Dissolution System (January 22, 2020)
  • K120005 — ACDS (March 29, 2012)
  • K041163 — ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES (October 7, 2004)
  • K993200 — MD 420/440/460/470/480/490 (January 24, 2000)

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)
  • 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