FDA 510(k)

ABL90 FLEX, ABL90 FLEX PLUS

N.º K: K170882 · 2017-04-28

Fecha de decisión2017-04-28

Código de productoMQM

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

ABL90 FLEX, ABL90 FLEX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170882. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ABL90 FLEX, ABL90 FLEX PLUS?

ABL90 FLEX, ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Radiometer Medical Aps. The 510(k) number is K170882.

When did ABL90 FLEX, ABL90 FLEX PLUS receive FDA 510(k) clearance?

ABL90 FLEX, ABL90 FLEX PLUS received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170882.

Who is the listed applicant for ABL90 FLEX, ABL90 FLEX PLUS?

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

What is the FDA product code for ABL90 FLEX, ABL90 FLEX PLUS?

The FDA product code for ABL90 FLEX, ABL90 FLEX PLUS is MQM.

Otros registros que enlistan a Radiometer Medical Aps 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.

K163462Kit de prueba Myo AQT90 FLEX, Kit de prueba CKMB AQT90 FLEX, AQT90 FLEX K160153ABL90 FLEX PLUS

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.