FDA 510(k)

デル타벤 빠른 플래시 클로즈드 I.V. 캐빈터 시스템

K-번호: K200373 · 2020-08-26

결정일2020-08-26

제품 코드FOZ

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

결정Substantially Equivalent

기기 요약

Deltaven Fast Flash Closed I.V. Catheter Systems is the device name listed in this FDA 510(k) record. The listed applicant is Delta Med Spa. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K200373. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Deltaven Fast Flash Closed I.V. Catheter Systems?

Deltaven Fast Flash Closed I.V. Catheter Systems is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Delta Med Spa. The 510(k) number is K200373.

When did Deltaven Fast Flash Closed I.V. Catheter Systems receive FDA 510(k) clearance?

Deltaven Fast Flash Closed I.V. Catheter Systems received FDA 510(k) clearance on 2020-08-26, under 510(k) number K200373.

Who is the listed applicant for Deltaven Fast Flash Closed I.V. Catheter Systems?

The FDA 510(k) record lists Delta Med Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deltaven Fast Flash Closed I.V. Catheter Systems?

The FDA product code for Deltaven Fast Flash Closed I.V. Catheter Systems is FOZ.

Delta Med Spa를 신청인으로 등재한 기타 기록

K171530デルタ벤 XiV 마ックス,德尔타벤 XiV 마ックス FF

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