FDA 510(k)

Full Automatic(NIBP) Blood Pressure Monitor

N.º K: K200521 · 2020-06-12

Fecha de decisión2020-06-12

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Full Automatic(NIBP) Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2020-06-12 under 510(k) number K200521. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Full Automatic(NIBP) Blood Pressure Monitor?

Full Automatic(NIBP) Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-06-12. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K200521.

When did Full Automatic(NIBP) Blood Pressure Monitor receive FDA 510(k) clearance?

Full Automatic(NIBP) Blood Pressure Monitor received FDA 510(k) clearance on 2020-06-12, under 510(k) number K200521.

Who is the listed applicant for Full Automatic(NIBP) Blood Pressure Monitor?

The FDA 510(k) record lists Health & Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Full Automatic(NIBP) Blood Pressure Monitor?

The FDA product code for Full Automatic(NIBP) Blood Pressure Monitor is DXN.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Health & Life Co., Ltd. como solicitante

K211744Non-Contact Infrared Thermometer, model HL710H K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM K190507Full Automatic (NIBP) Blood Pressure Monitor K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UB K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TB K180240Full Automatic(NIBP) Blood Pressure Monitor

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: DXN)

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.