FDA 510(k)

Vial2Bag Advanced 20mm Admixture Device

K-번호: K201415 · 2020-10-21

신청자West Pharmaceutical Services Az, Inc.

결정일2020-10-21

제품 코드LHI

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

결정Substantially Equivalent

기기 요약

Vial2Bag Advanced 20mm Admixture Device is the device name listed in this FDA 510(k) record. The listed applicant is West Pharmaceutical Services Az, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201415. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Vial2Bag Advanced 20mm Admixture Device?

Vial2Bag Advanced 20mm Admixture Device is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is West Pharmaceutical Services Az, Inc.. The 510(k) number is K201415.

When did Vial2Bag Advanced 20mm Admixture Device receive FDA 510(k) clearance?

Vial2Bag Advanced 20mm Admixture Device received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201415.

Who is the listed applicant for Vial2Bag Advanced 20mm Admixture Device?

The FDA 510(k) record lists West Pharmaceutical Services Az, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial2Bag Advanced 20mm Admixture Device?

The FDA product code for Vial2Bag Advanced 20mm Admixture Device is LHI.

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Vial2Bag Advanced 20mm Admixture Device

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LHI)

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