FDA 510(k)

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C

Número K: K161733 · 2017-03-08

Data da decisão2017-03-08

Código do produtoDTN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K161733. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K161733.

When did INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C receive FDA 510(k) clearance?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C received FDA 510(k) clearance on 2017-03-08, under 510(k) number K161733.

Who is the listed applicant for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

The FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is DTN.

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