FDA 510(k)

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K-번호: K212978 · 2021-11-10

결정일2021-11-10

제품 코드GEX

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

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기기 요약

Diode laser therapy system is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Unt Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212978. 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 Diode laser therapy system?

Diode laser therapy system is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Beijing Unt Technology Co., Ltd.. The 510(k) number is K212978.

When did Diode laser therapy system receive FDA 510(k) clearance?

Diode laser therapy system received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212978.

Who is the listed applicant for Diode laser therapy system?

The FDA 510(k) record lists Beijing Unt Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode laser therapy system?

The FDA product code for Diode laser therapy system is GEX. This falls under the Gastroenterology category.

Beijing Unt Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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