FDA 510(k)

FORA 고급 GD40 간헐혈당, ß-케톤, 콜레스테롤 모니터링 시스템

K-번호: K201037 · 2022-06-16

결정일2022-06-16

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

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K201037. 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 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K201037.

When did FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System receive FDA 510(k) clearance?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System received FDA 510(k) clearance on 2022-06-16, under 510(k) number K201037.

Who is the listed applicant for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

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

What is the FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

The FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is NBW. This falls under the OB/GYN category.

Taidoc Technology Corporation를 신청인으로 등재한 기타 기록

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