FDA 510(k)

Monitor de Presión Arterial Automático Digital Scian, Modelo: LD-576, LD-575 y LD-579

N.º K: K170866 · 2018-02-21

Fecha de decisión2018-02-21

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2018-02-21 under 510(k) number K170866. 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 Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K170866.

When did Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 receive FDA 510(k) clearance?

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 received FDA 510(k) clearance on 2018-02-21, under 510(k) number K170866.

Who is the listed applicant for Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

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

What is the FDA product code for Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

The FDA product code for Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 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 Honsun (Nantong) Co., Ltd. como solicitante

K262658Automatic Digital Blood Pressure monitor (LD-526)K252399Portable Oxygen Concentrator K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)K251795Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)K211629Infrared forehead thermometer LD-FT-100B K192500Esfigmomanómetro aneróide con estetoscopio, Esfigmomanómetro aneróide

Ver todos los 9 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.