FDA 510(k)

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

K-번호: K210661 · 2021-08-12

결정일2021-08-12

제품 코드KDI

자문 위원회GU

결정Substantially Equivalent

기기 요약

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset 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 2021-08-12 under 510(k) number K210661. 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 Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset?

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset is a medical device that received FDA 510(k) clearance on 2021-08-12. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K210661.

When did SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset receive FDA 510(k) clearance?

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset received FDA 510(k) clearance on 2021-08-12, under 510(k) number K210661.

Who is the listed applicant for SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset?

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 Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset?

The FDA product code for SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset 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)K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

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