FDA 510(k)

BGM014 혈당 모니터링 시스템, BGM014 프로 혈당 모니터링 시스템

K-번호: K161299 · 2016-12-23

결정일2016-12-23

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

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K161299. 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 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System?

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K161299.

When did BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System receive FDA 510(k) clearance?

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-12-23, under 510(k) number K161299.

Who is the listed applicant for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System?

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

What is the FDA product code for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System?

The FDA product code for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.