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FDA 510(k)

Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay

N.º K: K162002 · 2016-11-01

SolicitanteZdi, Solutions, LLC
Fecha de decisión2016-11-01
Código de productoIYE
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay is the device name listed in this FDA 510(k) record. The listed applicant is Zdi, Solutions, LLC. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162002. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay?

Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Zdi, Solutions, LLC. The 510(k) number is K162002.

When did Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay receive FDA 510(k) clearance?

Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162002.

Who is the listed applicant for Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay?

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

What is the FDA product code for Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay?

The FDA product code for Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay is IYE.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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