FDA 510(k)

möller 메디칼 브이오피스티 라이너스 및 시스템

K-번호: K162588 · 2017-06-19

결정일2017-06-19

제품 코드KNW

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Möller Medical Biopsy Needles and Systems is the device name listed in this FDA 510(k) record. The listed applicant is Moller Medical GmbH. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K162588. 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 Möller Medical Biopsy Needles and Systems?

Möller Medical Biopsy Needles and Systems is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Moller Medical GmbH. The 510(k) number is K162588.

When did Möller Medical Biopsy Needles and Systems receive FDA 510(k) clearance?

Möller Medical Biopsy Needles and Systems received FDA 510(k) clearance on 2017-06-19, under 510(k) number K162588.

Who is the listed applicant for Möller Medical Biopsy Needles and Systems?

The FDA 510(k) record lists Moller Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Möller Medical Biopsy Needles and Systems?

The FDA product code for Möller Medical Biopsy Needles and Systems is KNW.

공식 출처

FDA 데이터베이스에서 보기 →

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

möller 메디칼 브이오피스티 라이너스 및 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KNW)

공식 출처