FDA 510(k)

Patient Monitoring Cable (SpO2 Extension Cable)

K-번호: K192404 · 2020-06-22

결정일2020-06-22

제품 코드DSA

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정Substantially Equivalent

기기 요약

Patient Monitoring Cable (SpO2 Extension Cable) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K192404. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Patient Monitoring Cable (SpO2 Extension Cable)?

Patient Monitoring Cable (SpO2 Extension Cable) is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K192404.

When did Patient Monitoring Cable (SpO2 Extension Cable) receive FDA 510(k) clearance?

Patient Monitoring Cable (SpO2 Extension Cable) received FDA 510(k) clearance on 2020-06-22, under 510(k) number K192404.

Who is the listed applicant for Patient Monitoring Cable (SpO2 Extension Cable)?

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

What is the FDA product code for Patient Monitoring Cable (SpO2 Extension Cable)?

The FDA product code for Patient Monitoring Cable (SpO2 Extension Cable) is DSA.

Shenzhen Coreray Technology, Ltd.를 신청인으로 등재한 기타 기록

K173368Reusable & Disposable SpO2 Sensors K172797ECG Cable/Leadwires

관련 기기 (코드: DSA)

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