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FDA PMA

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy

Número do PMA: P030006 · 2018-11-21

RequerenteMedifocus, Inc.
Data da decisão2018-11-21
Número PMAP030006
Código do produtoMEQ
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoGU

Resumo do dispositivo

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy is the device name listed in this FDA 510(k) record. The listed applicant is Medifocus, Inc.. It received FDA 510(k) clearance on 2018-11-21. The device is classified under product code MEQ. It was reviewed by the GU advisory panel.

Perguntas frequentes

What is the System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy?

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Medifocus, Inc..

When did System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy receive FDA 510(k) clearance?

The clearance date for System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy can be found in the official FDA records.

Who is the listed applicant for System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy?

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

What is the FDA product code for System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy?

The FDA product code for System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy is MEQ.

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Fonte oficial

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