FDA 510(k)

T-Cuff

N.º K: K162365 · 2017-02-16

Fecha de decisión2017-02-16

Código de productoKCY

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

T-Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Terumobct, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162365. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the T-Cuff?

T-Cuff is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Terumobct, Inc.. The 510(k) number is K162365.

When did T-Cuff receive FDA 510(k) clearance?

T-Cuff received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162365.

Who is the listed applicant for T-Cuff?

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

What is the FDA product code for T-Cuff?

The FDA product code for T-Cuff is KCY.

Otros registros que enlistan a Terumobct, Inc. como solicitante

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.

K183081Spectra Optia Apheresis System K181049Spectra Optia Apheresis System K172590Spectra Optia Apheresis System K153601Spectra Optia Apheresis System

Dispositivos relacionados (Código: KCY)

K202919ATS 5000 Torniquete Automático InstrumentoMcewen and Associates Consulting , 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.