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FDA 510(k)

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

N.º K: K242269 · 2024-11-01

SolicitanteQuanta Dialysis Technologies, Ltd.
Fecha de decisión2024-11-01
Código de productoONW
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is the device name listed in this FDA 510(k) record. The listed applicant is Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242269. The device is classified under product code ONW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K242269.

When did SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) receive FDA 510(k) clearance?

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242269.

Who is the listed applicant for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

The FDA 510(k) record lists Quanta Dialysis Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

The FDA product code for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is ONW.

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Otros registros que enlistan a Quanta Dialysis Technologies, Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetK210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetK193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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