FDA 510(k)

MX40 Release C.01

K-번호: K180017 · 2018-07-24

결정일2018-07-24

제품 코드MHX

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

MX40 Release C.01 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K180017. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MX40 Release C.01?

MX40 Release C.01 is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Philips Medical Systems. The 510(k) number is K180017.

When did MX40 Release C.01 receive FDA 510(k) clearance?

MX40 Release C.01 received FDA 510(k) clearance on 2018-07-24, under 510(k) number K180017.

Who is the listed applicant for MX40 Release C.01?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MX40 Release C.01?

The FDA product code for MX40 Release C.01 is MHX.

Philips Medical Systems를 신청인으로 등재한 기타 기록

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph K191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph K192875Philips Biosensor BX100 K183387M3290B Patient Information Center iX

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