FDA 510(k)

HumaPen Savvio

Numéro K : K160668 · 2016-06-03

Date de décision2016-06-03

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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