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FDA 510(k)

HumaPen Savvio

N.º K: K160668 · 2016-06-03

SolicitanteEli Lilly and Company, Inc.
Fecha de decisión2016-06-03
Código de productoFMF
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

HumaPen Savvio is the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K160668. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HumaPen Savvio?

HumaPen Savvio is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Eli Lilly and Company, Inc.. The 510(k) number is K160668.

When did HumaPen Savvio receive FDA 510(k) clearance?

HumaPen Savvio received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160668.

Who is the listed applicant for HumaPen Savvio?

The FDA 510(k) record lists Eli Lilly and Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HumaPen Savvio?

The FDA product code for HumaPen Savvio is FMF.

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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.

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