FDA 510(k)

QUANTIEN Measurement System

Número K: K172182 · 2017-08-18

RequerenteSt. Jude Medical (Now Part of the Abbott Medical)

Data da decisão2017-08-18

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

QUANTIEN Measurement System is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical (Now Part of the Abbott Medical). It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K172182. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the QUANTIEN Measurement System?

QUANTIEN Measurement System is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is St. Jude Medical (Now Part of the Abbott Medical). The 510(k) number is K172182.

When did QUANTIEN Measurement System receive FDA 510(k) clearance?

QUANTIEN Measurement System received FDA 510(k) clearance on 2017-08-18, under 510(k) number K172182.

Who is the listed applicant for QUANTIEN Measurement System?

The FDA 510(k) record lists St. Jude Medical (Now Part of the Abbott Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIEN Measurement System?

The FDA product code for QUANTIEN Measurement System is DQK.

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