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FDA PMA

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

PMA Number: P030006 · 2018-11-21

ApplicantMedifocus, Inc.
Decision Date2018-11-21
PMA NumberP030006
Product CodeMEQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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