FDA 510(k)

IMD의 레이저 뇌수술針

K-번호: K170112 · 2018-02-02

신청자International Medical Development, Inc.(Imd)

결정일2018-02-02

제품 코드BSP

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

IMD's Lumbar Puncture Needle is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Development, Inc.(Imd). It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K170112. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the IMD's Lumbar Puncture Needle?

IMD's Lumbar Puncture Needle is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is International Medical Development, Inc.(Imd). The 510(k) number is K170112.

When did IMD's Lumbar Puncture Needle receive FDA 510(k) clearance?

IMD's Lumbar Puncture Needle received FDA 510(k) clearance on 2018-02-02, under 510(k) number K170112.

Who is the listed applicant for IMD's Lumbar Puncture Needle?

The FDA 510(k) record lists International Medical Development, Inc.(Imd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMD's Lumbar Puncture Needle?

The FDA product code for IMD's Lumbar Puncture Needle is BSP.

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IMD의 레이저 뇌수술針

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BSP)

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