FDA 510(k)

TEVADAPTOR Closed Drug Reconstitution and Transfer System

K-번호: K170680 · 2017-05-16

결정일2017-05-16

제품 코드ONB

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

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기기 요약

TEVADAPTOR Closed Drug Reconstitution and Transfer System is the device name listed in this FDA 510(k) record. The listed applicant is Teva Medical Ltd., Migada Plant. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K170680. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TEVADAPTOR Closed Drug Reconstitution and Transfer System?

TEVADAPTOR Closed Drug Reconstitution and Transfer System is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Teva Medical Ltd., Migada Plant. The 510(k) number is K170680.

When did TEVADAPTOR Closed Drug Reconstitution and Transfer System receive FDA 510(k) clearance?

TEVADAPTOR Closed Drug Reconstitution and Transfer System received FDA 510(k) clearance on 2017-05-16, under 510(k) number K170680.

Who is the listed applicant for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

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

What is the FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System is ONB.

Teva Medical Ltd., Migada Plant를 신청인으로 등재한 기타 기록

K180489TEVADAPTOR Closed Drug Reconstitution and Transfer System

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