FDA 510(k)

Invacare TDX SP2-HD with Captain's Seat

N.º K: K182946 · 2018-12-11

Fecha de decisión2018-12-11

Código de productoITI

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Invacare TDX SP2-HD with Captain's Seat is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2018-12-11 under 510(k) number K182946. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Invacare TDX SP2-HD with Captain's Seat?

Invacare TDX SP2-HD with Captain's Seat is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is Invacare Corporation. The 510(k) number is K182946.

When did Invacare TDX SP2-HD with Captain's Seat receive FDA 510(k) clearance?

Invacare TDX SP2-HD with Captain's Seat received FDA 510(k) clearance on 2018-12-11, under 510(k) number K182946.

Who is the listed applicant for Invacare TDX SP2-HD with Captain's Seat?

The FDA 510(k) record lists Invacare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Invacare TDX SP2-HD with Captain's Seat?

The FDA product code for Invacare TDX SP2-HD with Captain's Seat is ITI.

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 Invacare Corporation como solicitante

K203210Invacare Platinum 5NXG Oxygen Concentrator K202379Invacare AVIVA Storm RX Power Chair K200890Invacare Perfecto2V Oxygen Concentrator K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity K181090Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: ITI)

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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.