FDA 510(k)

CO2 레이저 치료 시스템

K-번호: K192528 · 2019-12-03

신청자Shangdong Huamei Technology Co., Ltd.

결정일2019-12-03

제품 코드GEX

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

결정대체적으로 동일

기기 요약

CO2 Laser Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-03 under 510(k) number K192528. 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 CO2 Laser Therapy System?

CO2 Laser Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K192528.

When did CO2 Laser Therapy System receive FDA 510(k) clearance?

CO2 Laser Therapy System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K192528.

Who is the listed applicant for CO2 Laser Therapy System?

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

What is the FDA product code for CO2 Laser Therapy System?

The FDA product code for CO2 Laser Therapy System is GEX. This falls under the Gastroenterology category.

Shangdong Huamei Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K230816강한 파동 조명 치료 시스템 K202758Nd: YAG 레이저 치료 시스템 HM-YL900 K200751포토동력요법 장비 K192521강한 파동 조명 치료 시스템

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