FDA 510(k)

라이어스트 혈당 모니터링 시스템 GM700S, 라이어스트 혈당 모니터링 시스템 GM700SB

K-번호: K190564 · 2019-06-02

결정일2019-06-02

제품 코드NBW

자문 위원회CH [기업명]의 [제품명]은 미국 식품의약국(FDA)에서 510(k) 등록을 완료한 의료기기입니다. 이 제품은 [PMA] 및 [NCT] 등록을 완료하였으며, [PMID]로 확인할 수 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL].

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기기 요약

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2019-06-02 under 510(k) number K190564. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is a medical device that received FDA 510(k) clearance on 2019-06-02. The listed applicant is Bionime Corporation. The 510(k) number is K190564.

When did Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB receive FDA 510(k) clearance?

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB received FDA 510(k) clearance on 2019-06-02, under 510(k) number K190564.

Who is the listed applicant for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

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

What is the FDA product code for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

The FDA product code for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is NBW. This falls under the OB/GYN category.

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