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FDA 510(k)

FLOWpresso

N.º K: K223729 · 2023-12-21

SolicitanteMedella Health Limited
Fecha de decisión2023-12-21
Código de productoIRP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

FLOWpresso is the device name listed in this FDA 510(k) record. The listed applicant is Medella Health Limited. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K223729. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FLOWpresso?

FLOWpresso is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Medella Health Limited. The 510(k) number is K223729.

When did FLOWpresso receive FDA 510(k) clearance?

FLOWpresso received FDA 510(k) clearance on 2023-12-21, under 510(k) number K223729.

Who is the listed applicant for FLOWpresso?

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

What is the FDA product code for FLOWpresso?

The FDA product code for FLOWpresso is IRP.

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Fuente oficial

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