TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM— 510(k) K093641
Substantially EquivalentTango3, LLC
FDA 510(k) clearance K093641 for TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM, Substantially Equivalent on 2010-12-08. Applicant: Tango3, LLC. Device class: 2.
Clearance details
- Applicant
- Tango3, LLC
- Product code
- Code FIN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Simpsonville, KY, US
Recent devices under product code FIN
view all- K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K141213 — AMERIWATER OZONE DISINFECTION SYSTEM
- K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM
- K060333 — DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
- K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
Recalls naming K093641
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093641.
Data sourced from openFDA. This site is unofficial and independent of the FDA.