FDA 510(k)

Smart Syringe

Número K: K171698 · 2017-07-07

Data da decisão2017-07-07

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Osprey Medical, Inc.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K171698. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart Syringe?

Smart Syringe is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K171698.

When did Smart Syringe receive FDA 510(k) clearance?

Smart Syringe received FDA 510(k) clearance on 2017-07-07, under 510(k) number K171698.

Who is the listed applicant for Smart Syringe?

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

What is the FDA product code for Smart Syringe?

The FDA product code for Smart Syringe is DXT.

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Fonte oficial

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