FDA 510(k)

Patient Cables and Leadwires , Disposable ECG Leadwires

K-번호: K182327 · 2019-01-30

결정일2019-01-30

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 Cables and Leadwires , Disposable ECG Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2019-01-30 under 510(k) number K182327. 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 Cables and Leadwires , Disposable ECG Leadwires?

Patient Cables and Leadwires , Disposable ECG Leadwires is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Orantech, Inc.. The 510(k) number is K182327.

When did Patient Cables and Leadwires , Disposable ECG Leadwires receive FDA 510(k) clearance?

Patient Cables and Leadwires , Disposable ECG Leadwires received FDA 510(k) clearance on 2019-01-30, under 510(k) number K182327.

Who is the listed applicant for Patient Cables and Leadwires , Disposable ECG Leadwires?

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

What is the FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires?

The FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires is DSA.

Orantech, Inc.를 신청인으로 등재한 기타 기록

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관련 기기 (코드: DSA)

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