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FDA 510(k)

OK Handpiece

N.º K: K221814 · 2022-07-15

SolicitanteJaintek Co.,Ltd
Fecha de decisión2022-07-15
Código de productoEFB
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

OK Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Jaintek Co.,Ltd. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221814. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OK Handpiece?

OK Handpiece is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Jaintek Co.,Ltd. The 510(k) number is K221814.

When did OK Handpiece receive FDA 510(k) clearance?

OK Handpiece received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221814.

Who is the listed applicant for OK Handpiece?

The FDA 510(k) record lists Jaintek Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OK Handpiece?

The FDA product code for OK Handpiece is EFB.

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Dispositivos relacionados (Código: EFB)

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

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