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FDA 510(k)

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)

K-번호: K172739 · 2017-10-10

신청자Higi Sh, LLC
결정일2017-10-10
제품 코드DXN
자문 위원회CV
결정Substantially Equivalent

기기 요약

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is the device name listed in this FDA 510(k) record. The listed applicant is Higi Sh, LLC. It received FDA 510(k) clearance on 2017-10-10 under 510(k) number K172739. 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 higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is a medical device that received FDA 510(k) clearance on 2017-10-10. The listed applicant is Higi Sh, LLC. The 510(k) number is K172739.

When did higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) receive FDA 510(k) clearance?

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) received FDA 510(k) clearance on 2017-10-10, under 510(k) number K172739.

Who is the listed applicant for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

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

What is the FDA product code for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

The FDA product code for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is DXN.

관련 임상시험

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING

관련 기기 (코드: DXN)

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

공식 출처

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