DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM— 510(k) K060333

Name: FDA 510(k) clearance K060333
Creator: U.S. Food and Drug Administration
Published: 2006-09-08

Substantially Equivalent

Dialysis Services, Inc.

FDA 510(k) clearance K060333 for DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM, Substantially Equivalent on 2006-09-08. Applicant: Dialysis Services, Inc.. Device class: 2.

Clearance details

Applicant: Dialysis Services, Inc.
Product code: Code FIN
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2006-02-09
Decision date: 2006-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FIN

view all

K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM2015-01-12
K141213 — AMERIWATER OZONE DISINFECTION SYSTEM2014-12-10
K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM2012-01-26
K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM2010-12-08
K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS2006-01-06

More clearances from Dialysis Services, Inc.

view all

K043344 — DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM2005-03-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.