AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS

FDA 510(k) clearance K051031 · decided 2006-01-06

Clearance details

K-number: K051031
Device name: AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
Applicant: Ameriwater
Decision: Substantially Equivalent
Date received: 2005-04-22
Decision date: 2006-01-06
Days to decision: 259 days
Clearance type: Traditional
Product code: FIN
Device class: 2
Regulation number: 876.5820
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Dayton, OH, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K140984)	Tango3, LLC	2015-01-12
AMERIWATER OZONE DISINFECTION SYSTEM (K141213)	Ameriwater	2014-12-10
BICARB MIXING AND DISTRIBUTION SYSTEM (K112427)	Isopure, Corp.	2012-01-26
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K093641)	Tango3, LLC	2010-12-08
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM (K060333)	Dialysis Services, Inc.	2006-09-08
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (K031502)	Usfilter	2004-08-27
BIPRO MODEL SDS-CB200 (K033118)	Medical Solutions International	2004-06-28
BICARD MIXING SYSTEM (K030366)	Dialysis Systems, Inc.	2004-04-19
OSMONICS SOLUTION DELIVERY SYSTEM (K023011)	Osmonics Medical Systems	2003-06-26
MAR COR SERVICES BICARB SYSTEM (K003560)	Mar Cor Services, Inc.	2001-06-08
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM (K993272)	Pure Water, Inc.	2000-04-10
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL (K993058)	Pure Water, Inc.	2000-01-24

No recalls on record reference this clearance.