FDA 510(k)

레이저 치료 시스템, 모델: Hera, Armo

K-번호: K212793 · 2021-10-25

신청자Canadian Pioneer Medical Technology Corporation

결정일2021-10-25

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Laser Treatment System, Model: Hera, Armo is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Pioneer Medical Technology Corporation. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K212793. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Laser Treatment System, Model: Hera, Armo?

Laser Treatment System, Model: Hera, Armo is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Canadian Pioneer Medical Technology Corporation. The 510(k) number is K212793.

When did Laser Treatment System, Model: Hera, Armo receive FDA 510(k) clearance?

Laser Treatment System, Model: Hera, Armo received FDA 510(k) clearance on 2021-10-25, under 510(k) number K212793.

Who is the listed applicant for Laser Treatment System, Model: Hera, Armo?

The FDA 510(k) record lists Canadian Pioneer Medical Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser Treatment System, Model: Hera, Armo?

The FDA product code for Laser Treatment System, Model: Hera, Armo is GEX. This falls under the Gastroenterology category.

Canadian Pioneer Medical Technology Corporation를 신청인으로 등재한 기타 기록

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