FDA 510(k)

Intellifuse Administration and Intellifuse Blood Administration Sets

Numéro K : K192375 · 2020-09-18

Date de décision2020-09-18

Code produitFPA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Intellifuse Administration and Intellifuse Blood Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K192375. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Intellifuse Administration and Intellifuse Blood Administration Sets?

Intellifuse Administration and Intellifuse Blood Administration Sets is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K192375.

When did Intellifuse Administration and Intellifuse Blood Administration Sets receive FDA 510(k) clearance?

Intellifuse Administration and Intellifuse Blood Administration Sets received FDA 510(k) clearance on 2020-09-18, under 510(k) number K192375.

Who is the listed applicant for Intellifuse Administration and Intellifuse Blood Administration Sets?

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

What is the FDA product code for Intellifuse Administration and Intellifuse Blood Administration Sets?

The FDA product code for Intellifuse Administration and Intellifuse Blood Administration Sets is FPA.

Essais cliniques associés

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Source officielle

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