FDA 510(k)

Digital Automatic Wrist Blood Pressure Monitor MD4300

K-번호: K171379 · 2018-04-10

신청자Grandway Technology (Shenzhen) Limited

결정일2018-04-10

제품 코드DXN

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

Digital Automatic Wrist Blood Pressure Monitor MD4300 is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K171379. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Digital Automatic Wrist Blood Pressure Monitor MD4300?

Digital Automatic Wrist Blood Pressure Monitor MD4300 is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K171379.

When did Digital Automatic Wrist Blood Pressure Monitor MD4300 receive FDA 510(k) clearance?

Digital Automatic Wrist Blood Pressure Monitor MD4300 received FDA 510(k) clearance on 2018-04-10, under 510(k) number K171379.

Who is the listed applicant for Digital Automatic Wrist Blood Pressure Monitor MD4300?

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

What is the FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300?

The FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300 is DXN.

Grandway Technology (Shenzhen) Limited를 신청인으로 등재한 기타 기록

K191593Digital Automatic Blood Pressure Monitor MD36 Series K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series K163679Digital Automatic Blood Pressure Monitor MD3600 K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

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