FDA 510(k)

Mortara Surveyor Patient Monitor

Número K: K161517 · 2017-01-11

Data da decisão2017-01-11

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mortara Surveyor Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K161517. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mortara Surveyor Patient Monitor?

Mortara Surveyor Patient Monitor is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K161517.

When did Mortara Surveyor Patient Monitor receive FDA 510(k) clearance?

Mortara Surveyor Patient Monitor received FDA 510(k) clearance on 2017-01-11, under 510(k) number K161517.

Who is the listed applicant for Mortara Surveyor Patient Monitor?

The FDA 510(k) record lists Mortara Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mortara Surveyor Patient Monitor?

The FDA product code for Mortara Surveyor Patient Monitor is MHX.

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Fonte oficial

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