FDA 510(k)

M-Wave

N.º K: K233485 · 2024-01-26

Fecha de decisión2024-01-26

Código de productoIPF

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

M-Wave is the device name listed in this FDA 510(k) record. The listed applicant is Zynex Medical, Inc.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K233485. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the M-Wave?

M-Wave is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Zynex Medical, Inc.. The 510(k) number is K233485.

When did M-Wave receive FDA 510(k) clearance?

M-Wave received FDA 510(k) clearance on 2024-01-26, under 510(k) number K233485.

Who is the listed applicant for M-Wave?

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

What is the FDA product code for M-Wave?

The FDA product code for M-Wave is IPF.

Otros registros que enlistan a Zynex Medical, 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.

K223217Zynex Monitoring System, Model CM-1600 K191697Cardiac Monitor 1500

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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.