FDA 510(k)

e-SDF

N.º K: K240619 · 2024-03-06

Fecha de decisión2024-03-06

Código de productoPHR

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

e-SDF is the device name listed in this FDA 510(k) record. The listed applicant is Kids-E-Dental Llp. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K240619. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the e-SDF?

e-SDF is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Kids-E-Dental Llp. The 510(k) number is K240619.

When did e-SDF receive FDA 510(k) clearance?

e-SDF received FDA 510(k) clearance on 2024-03-06, under 510(k) number K240619.

Who is the listed applicant for e-SDF?

The FDA 510(k) record lists Kids-E-Dental Llp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e-SDF?

The FDA product code for e-SDF is PHR.

Dispositivos relacionados (Código: PHR)

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.

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Fuente oficial

Ver en la base de datos de la FDA →

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