FDA 510(k)

글루코카드 쉬인 콘넥스 혈당 모니터링 시스템, 글루코카드 쉬인 엑스프레스 혈당 모니터링 시스템

K-번호: K181273 · 2018-11-01

결정일2018-11-01

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].

결정대체적으로 동일

기기 요약

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K181273. 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 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System?

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is I-Sens, Inc.. The 510(k) number is K181273.

When did GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System receive FDA 510(k) clearance?

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-11-01, under 510(k) number K181273.

Who is the listed applicant for GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System?

The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System?

The FDA product code for GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.