FDA 510(k)

Finger Pulse Oximeter, Model: X1906P

N.º K: K221798 · 2023-05-04

SolicitanteShenzhen Changkun Technology Co., Ltd.

Fecha de decisión2023-05-04

Código de productoDQA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Finger Pulse Oximeter, Model: X1906P is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K221798. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Finger Pulse Oximeter, Model: X1906P?

Finger Pulse Oximeter, Model: X1906P is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K221798.

When did Finger Pulse Oximeter, Model: X1906P receive FDA 510(k) clearance?

Finger Pulse Oximeter, Model: X1906P received FDA 510(k) clearance on 2023-05-04, under 510(k) number K221798.

Who is the listed applicant for Finger Pulse Oximeter, Model: X1906P?

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

What is the FDA product code for Finger Pulse Oximeter, Model: X1906P?

The FDA product code for Finger Pulse Oximeter, Model: X1906P is DQA.

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 Shenzhen Changkun Technology Co., Ltd. como solicitante

K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)K231595Electric Breast Pump K193386Wrist Electronic Sphygmomanometer K193387Esfigmomanómetro Electrónico de brazo K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448Pulsoxímetro AViTA (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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.