FDA 510(k)

린쇼밍 호흡 모니터링 장치 (LRMD)

K-번호: K190734 · 2020-01-30

결정일2020-01-30

제품 코드BZQ

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

Linshom Respiratory Monitoring Device (LRMD) is the device name listed in this FDA 510(k) record. The listed applicant is Linshom Management, LLC. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K190734. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Linshom Respiratory Monitoring Device (LRMD)?

Linshom Respiratory Monitoring Device (LRMD) is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Linshom Management, LLC. The 510(k) number is K190734.

When did Linshom Respiratory Monitoring Device (LRMD) receive FDA 510(k) clearance?

Linshom Respiratory Monitoring Device (LRMD) received FDA 510(k) clearance on 2020-01-30, under 510(k) number K190734.

Who is the listed applicant for Linshom Respiratory Monitoring Device (LRMD)?

The FDA 510(k) record lists Linshom Management, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Linshom Respiratory Monitoring Device (LRMD)?

The FDA product code for Linshom Respiratory Monitoring Device (LRMD) is BZQ.

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린쇼밍 호흡 모니터링 장치 (LRMD)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BZQ)

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