FDA 510(k)

PageWriter TC35 Cardiograph

Número K: K221141 · 2022-12-02

RequerenteMedizin Systeme Boblingen GmbH

Data da decisão2022-12-02

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

PageWriter TC35 Cardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Medizin Systeme Boblingen GmbH. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221141. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PageWriter TC35 Cardiograph?

PageWriter TC35 Cardiograph is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Medizin Systeme Boblingen GmbH. The 510(k) number is K221141.

When did PageWriter TC35 Cardiograph receive FDA 510(k) clearance?

PageWriter TC35 Cardiograph received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221141.

Who is the listed applicant for PageWriter TC35 Cardiograph?

The FDA 510(k) record lists Medizin Systeme Boblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PageWriter TC35 Cardiograph?

The FDA product code for PageWriter TC35 Cardiograph is DPS.

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