BICARD MIXING SYSTEM— 510(k) K030366
Substantially EquivalentDialysis Systems, Inc.
FDA 510(k) clearance K030366 for BICARD MIXING SYSTEM, Substantially Equivalent on 2004-04-19. Applicant: Dialysis Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Dialysis Systems, Inc.
- 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
- Nashville, TN, 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
- K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K060333 — DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
More clearances from Dialysis Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.