FDA 510(k)

DOC Band 3D

N.º K: K244056 · 2025-03-17

Fecha de decisión2025-03-17

Código de productoOAN

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

DOC Band 3D is the device name listed in this FDA 510(k) record. The listed applicant is Cranial Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-17 under 510(k) number K244056. The device is classified under product code OAN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DOC Band 3D?

DOC Band 3D is a medical device that received FDA 510(k) clearance on 2025-03-17. The listed applicant is Cranial Technologies, Inc.. The 510(k) number is K244056.

When did DOC Band 3D receive FDA 510(k) clearance?

DOC Band 3D received FDA 510(k) clearance on 2025-03-17, under 510(k) number K244056.

Who is the listed applicant for DOC Band 3D?

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

What is the FDA product code for DOC Band 3D?

The FDA product code for DOC Band 3D is OAN.

Dispositivos relacionados (Código: OAN)

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.

K240466STARband 3DOrthomerica Products, Inc.K211376STARbandOrthomerica Products, Inc.K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K161138St. Louis BandOrthomerica Products, Inc.

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.