Atlas FDA

TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM

FDA 510(k) clearance K093641 · decided 2010-12-08

Clearance details

K-number
K093641
Device name
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
Applicant
Tango3, LLC
Decision
Substantially Equivalent
Date received
2009-11-24
Decision date
2010-12-08
Days to decision
379 days
Clearance type
Traditional
Product code
FIN
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Simpsonville, KY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K140984)Tango3, LLC2015-01-12
AMERIWATER OZONE DISINFECTION SYSTEM (K141213)Ameriwater2014-12-10
BICARB MIXING AND DISTRIBUTION SYSTEM (K112427)Isopure, Corp.2012-01-26
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM (K060333)Dialysis Services, Inc.2006-09-08
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (K051031)Ameriwater2006-01-06
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (K031502)Usfilter2004-08-27
BIPRO MODEL SDS-CB200 (K033118)Medical Solutions International2004-06-28
BICARD MIXING SYSTEM (K030366)Dialysis Systems, Inc.2004-04-19
OSMONICS SOLUTION DELIVERY SYSTEM (K023011)Osmonics Medical Systems2003-06-26
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

Recalls involving this device

RecordFirmDate
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., recall (Z-2138-2012)Tango3 LLC2012-08-03