FDA PMA

시스템, 고온치료,射频/マイ크로파(良性前列腺增生), 테르모θε라피

PMA 번호: P010055 · 2021-06-30

신청자Prostalund AB

결정일2021-06-30

PMA 번호P010055

제품 코드MEQ

의료기기 등급등급 3

의학적 전문분야U

자문 위원회규제 정책: medical-regulatory-v1 GU

기기 요약

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.

자주 묻는 질문

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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