FDA 510(k)

RHEA Vital Sign 경계 시스템

K-번호: K190775 · 2019-12-19

신청자Shenzhen Fiber Medical Technology Co. , Ltd.

결정일2019-12-19

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

The RHEA Vital Sign Vigilance System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Fiber Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190775. 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 The RHEA Vital Sign Vigilance System?

The RHEA Vital Sign Vigilance System is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Shenzhen Fiber Medical Technology Co. , Ltd.. The 510(k) number is K190775.

When did The RHEA Vital Sign Vigilance System receive FDA 510(k) clearance?

The RHEA Vital Sign Vigilance System received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190775.

Who is the listed applicant for The RHEA Vital Sign Vigilance System?

The FDA 510(k) record lists Shenzhen Fiber Medical Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The RHEA Vital Sign Vigilance System?

The FDA product code for The RHEA Vital Sign Vigilance System is BZQ.

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RHEA Vital Sign 경계 시스템

기기 요약

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관련 임상시험

관련 기기 (코드: BZQ)

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