FDA 510(k)

SOLOPASS System

Número K: K203251 · 2021-08-27

RequerenteIntravent Medical Partners, LP

Data da decisão2021-08-27

Código do produtoHAW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SOLOPASS System is the device name listed in this FDA 510(k) record. The listed applicant is Intravent Medical Partners, LP. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K203251. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SOLOPASS System?

SOLOPASS System is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Intravent Medical Partners, LP. The 510(k) number is K203251.

When did SOLOPASS System receive FDA 510(k) clearance?

SOLOPASS System received FDA 510(k) clearance on 2021-08-27, under 510(k) number K203251.

Who is the listed applicant for SOLOPASS System?

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

What is the FDA product code for SOLOPASS System?

The FDA product code for SOLOPASS System is HAW.

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