FDA 510(k)

M-바이오플로이 세미자동 바이오플로이 도구 M-바이오플로이 코아크시얼 인트로듀서 나일리드를 위한 세미

K-번호: K161409 · 2016-08-02

결정일2016-08-02

제품 코드KNW

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is the device name listed in this FDA 510(k) record. The listed applicant is Mermaid Medical A/S. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K161409. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Mermaid Medical A/S. The 510(k) number is K161409.

When did M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem receive FDA 510(k) clearance?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem received FDA 510(k) clearance on 2016-08-02, under 510(k) number K161409.

Who is the listed applicant for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

The FDA 510(k) record lists Mermaid Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

The FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is KNW.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

M-바이오플로이 세미자동 바이오플로이 도구 M-바이오플로이 코아크시얼 인트로듀서 나일리드를 위한 세미

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KNW)

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