FDA 510(k)

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

K-번호: K222067 · 2022-11-10

결정일2022-11-10

제품 코드KDI

자문 위원회GU

결정Substantially Equivalent

기기 요약

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set 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 2022-11-10 under 510(k) number K222067. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K222067.

When did SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set receive FDA 510(k) clearance?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222067.

Who is the listed applicant for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

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+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA product code for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is KDI.

Quanta Dialysis Technologies, Ltd.를 신청인으로 등재한 기타 기록

K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

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