SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)— 510(k) K242269

Substantially Equivalent

Quanta Dialysis Technologies, Ltd.

FDA 510(k) clearance K242269 for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651), Substantially Equivalent on 2024-11-01. Applicant: Quanta Dialysis Technologies, Ltd..

Clearance details

Applicant: Quanta Dialysis Technologies, Ltd.
Product code: Code ONW
Advisory panel: Gastroenterology, Urology
Date received: 2024-08-01
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, GB

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