FDA 510(k)

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L

K-번호: K170565 · 2017-08-01

결정일2017-08-01

제품 코드QYX

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

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is the device name listed in this FDA 510(k) record. The listed applicant is Lifewatch Services, Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170565. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Lifewatch Services, Inc.. The 510(k) number is K170565.

When did LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L receive FDA 510(k) clearance?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170565.

Who is the listed applicant for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

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

What is the FDA product code for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

The FDA product code for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is QYX.

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LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: QYX)

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