FDA 510(k)

니프로 드라이 컴플리트 드라이 아시드 콘센트 포 헴odialysis

K-번호: K193155 · 2020-11-25

결정일2020-11-25

제품 코드KPO

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Renal Solutions USA, Corp.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K193155. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Nipro Renal Solutions USA, Corp.. The 510(k) number is K193155.

When did Nipro Dry Complete Dry Acid Concentrate for Hemodialysis receive FDA 510(k) clearance?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis received FDA 510(k) clearance on 2020-11-25, under 510(k) number K193155.

Who is the listed applicant for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

The FDA 510(k) record lists Nipro Renal Solutions USA, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

The FDA product code for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is KPO.

Nipro Renal Solutions USA, Corp.를 신청인으로 등재한 기타 기록

K223431시트릭 컴플릿 액체 시트릭산 집중액

관련 기기 (코드: KPO)

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