FDA 510(k)

Cala Trio

N.º K: K203288 · 2021-10-05

Fecha de decisión2021-10-05

Código de productoQBC

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cala Trio is the device name listed in this FDA 510(k) record. The listed applicant is Cala Health, Inc.. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K203288. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cala Trio?

Cala Trio is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Cala Health, Inc.. The 510(k) number is K203288.

When did Cala Trio receive FDA 510(k) clearance?

Cala Trio received FDA 510(k) clearance on 2021-10-05, under 510(k) number K203288.

Who is the listed applicant for Cala Trio?

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

What is the FDA product code for Cala Trio?

The FDA product code for Cala Trio is QBC.

Otros registros que enlistan a Cala Health, 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.

K253587Cala kIQ Plus K243848Cala kIQ K242259Cala kIQ K222237Cala kIQ K182706External upper limb tremor stimulator

Dispositivos relacionados (Código: QBC)

K253587Cala kIQ PlusCala Health, Inc.K251517Encora X1Encora, Inc.K250096Felix NeuroAI SystemFasikl Incorporated K243848Cala kIQCala Health, Inc.K242259Cala kIQCala Health, Inc.K222237Cala kIQCala Health, 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.