FDA 510(k)

Full Automatic (NIBP) Blood Pressure Monitor-HL158UB

N.º K: K190133 · 2019-06-13

Fecha de decisión2019-06-13

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Full Automatic (NIBP) Blood Pressure Monitor-HL158UB 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 2019-06-13 under 510(k) number K190133. 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-HL158UB?

Full Automatic (NIBP) Blood Pressure Monitor-HL158UB is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K190133.

When did Full Automatic (NIBP) Blood Pressure Monitor-HL158UB receive FDA 510(k) clearance?

Full Automatic (NIBP) Blood Pressure Monitor-HL158UB received FDA 510(k) clearance on 2019-06-13, under 510(k) number K190133.

Who is the listed applicant for Full Automatic (NIBP) Blood Pressure Monitor-HL158UB?

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-HL158UB?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158UB 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 K200521Full Automatic(NIBP) Blood Pressure Monitor K190507Full Automatic (NIBP) Blood Pressure Monitor 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.