FDA 510(k)

전기수술 발생기 (ES-100); 전기수술 발생기 (ES-300)

K-번호: K240975 · 2024-12-23

신청자Beijing Taktvoll Technology Co., Ltd.

결정일2024-12-23

제품 코드GEI

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

결정Substantially Equivalent

기기 요약

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Taktvoll Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K240975. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Beijing Taktvoll Technology Co., Ltd.. The 510(k) number is K240975.

When did Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) receive FDA 510(k) clearance?

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) received FDA 510(k) clearance on 2024-12-23, under 510(k) number K240975.

Who is the listed applicant for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

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

What is the FDA product code for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

The FDA product code for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is GEI.

공식 출처

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전기수술 발생기 (ES-100); 전기수술 발생기 (ES-300)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEI)

공식 출처