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FDA PMA

系統,高溫治療,射频/微波(良性前列腺增生),熱療

PMA 核准號:P010055 · 2021-06-30

申請人Prostalund AB
決定日期2021-06-30
PMA 編號P010055
產品代碼MEQ
器械分類3 類
醫療專科U
諮詢委員會GU

器材摘要

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy is the device name listed in this FDA 510(k) record. The listed applicant is Prostalund AB. It received FDA 510(k) clearance on 2021-06-30. The device is classified under product code MEQ. It was reviewed by the GU advisory panel.

常見問題

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 2021-06-30. The listed applicant is Prostalund AB.

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 Prostalund AB 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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