FDA 510(k)

Vial Adapter Ø20 mm , Vial Adapter Ø13 mm

K-번호: K190816 · 2019-11-19

신청자Avenir Performance Europeenne Medical (Apem)

결정일2019-11-19

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

Vial Adapter Ø20 mm , Vial Adapter Ø13 mm is the device name listed in this FDA 510(k) record. The listed applicant is Avenir Performance Europeenne Medical (Apem). It received FDA 510(k) clearance on 2019-11-19 under 510(k) number K190816. 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 Vial Adapter Ø20 mm , Vial Adapter Ø13 mm?

Vial Adapter Ø20 mm , Vial Adapter Ø13 mm is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Avenir Performance Europeenne Medical (Apem). The 510(k) number is K190816.

When did Vial Adapter Ø20 mm , Vial Adapter Ø13 mm receive FDA 510(k) clearance?

Vial Adapter Ø20 mm , Vial Adapter Ø13 mm received FDA 510(k) clearance on 2019-11-19, under 510(k) number K190816.

Who is the listed applicant for Vial Adapter Ø20 mm , Vial Adapter Ø13 mm?

The FDA 510(k) record lists Avenir Performance Europeenne Medical (Apem) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial Adapter Ø20 mm , Vial Adapter Ø13 mm?

The FDA product code for Vial Adapter Ø20 mm , Vial Adapter Ø13 mm is LHI.

Avenir Performance Europeenne Medical (Apem)를 신청인으로 등재한 기타 기록

K190149Vial Adapter Ø20 mm

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