FDA 510(k)

KidCap

N.º K: K180568 · 2018-10-16

SolicitanteEastern Cranial Affiliates, LLC

Fecha de decisión2018-10-16

Código de productoMVA

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

KidCap is the device name listed in this FDA 510(k) record. The listed applicant is Eastern Cranial Affiliates, LLC. It received FDA 510(k) clearance on 2018-10-16 under 510(k) number K180568. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KidCap?

KidCap is a medical device that received FDA 510(k) clearance on 2018-10-16. The listed applicant is Eastern Cranial Affiliates, LLC. The 510(k) number is K180568.

When did KidCap receive FDA 510(k) clearance?

KidCap received FDA 510(k) clearance on 2018-10-16, under 510(k) number K180568.

Who is the listed applicant for KidCap?

The FDA 510(k) record lists Eastern Cranial Affiliates, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KidCap?

The FDA product code for KidCap is MVA.

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Fuente oficial

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