FDA 510(k)

PUREtrace™

Número K: K153262 · 2017-02-07

Data da decisão2017-02-07

Código do produtoOSP

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

PUREtrace™ is the device name listed in this FDA 510(k) record. The listed applicant is Nemo Healthcare BV. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K153262. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PUREtrace™?

PUREtrace™ is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Nemo Healthcare BV. The 510(k) number is K153262.

When did PUREtrace™ receive FDA 510(k) clearance?

PUREtrace™ received FDA 510(k) clearance on 2017-02-07, under 510(k) number K153262.

Who is the listed applicant for PUREtrace™?

The FDA 510(k) record lists Nemo Healthcare BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUREtrace™?

The FDA product code for PUREtrace™ is OSP.

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