FDA 510(k)

팔형 자동 혈압계 BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

K-번호: K172896 · 2018-01-26

신청자Shenzhen Jiacom Technology CO ., Ltd.

결정일2018-01-26

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

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jiacom Technology CO ., Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K172896. 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 Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312?

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Shenzhen Jiacom Technology CO ., Ltd.. The 510(k) number is K172896.

When did Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 receive FDA 510(k) clearance?

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 received FDA 510(k) clearance on 2018-01-26, under 510(k) number K172896.

Who is the listed applicant for Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312?

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

What is the FDA product code for Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312?

The FDA product code for Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 is DXN.

Shenzhen Jiacom Technology CO ., Ltd.를 신청인으로 등재한 기타 기록

K172874인프라레드 체온계 K172894인프라레드 체온계 K172972Wrist Type Automatic Blood Pressure Monitor

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