FDA 510(k)

사파이어 주사泵, 사파이어 관리 세트

K-번호: K192860 · 2020-11-19

결정일2020-11-19

제품 코드FRN

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Sapphire Infusion Pump, Sapphire administration sets is the device name listed in this FDA 510(k) record. The listed applicant is Q Core Medical , Ltd.. It received FDA 510(k) clearance on 2020-11-19 under 510(k) number K192860. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sapphire Infusion Pump, Sapphire administration sets?

Sapphire Infusion Pump, Sapphire administration sets is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is Q Core Medical , Ltd.. The 510(k) number is K192860.

When did Sapphire Infusion Pump, Sapphire administration sets receive FDA 510(k) clearance?

Sapphire Infusion Pump, Sapphire administration sets received FDA 510(k) clearance on 2020-11-19, under 510(k) number K192860.

Who is the listed applicant for Sapphire Infusion Pump, Sapphire administration sets?

The FDA 510(k) record lists Q Core Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sapphire Infusion Pump, Sapphire administration sets?

The FDA product code for Sapphire Infusion Pump, Sapphire administration sets is FRN.

Q Core Medical , Ltd.를 신청인으로 등재한 기타 기록

K161667사파이어 주사泵

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