FDA 510(k)

전기치료 전극

K-번호: K250841 · 2025-08-13

결정일2025-08-13

제품 코드GXY

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

Electrotherapy Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Baisheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K250841. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Electrotherapy Electrodes?

Electrotherapy Electrodes is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Baisheng Medical Co., Ltd.. The 510(k) number is K250841.

When did Electrotherapy Electrodes receive FDA 510(k) clearance?

Electrotherapy Electrodes received FDA 510(k) clearance on 2025-08-13, under 510(k) number K250841.

Who is the listed applicant for Electrotherapy Electrodes?

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

What is the FDA product code for Electrotherapy Electrodes?

The FDA product code for Electrotherapy Electrodes is GXY.

Baisheng Medical Co., Ltd.를 신청인으로 등재한 기타 기록

K251235전기수술 패드 K233615전기 수술 패드 (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1)K221815전기수술 펜 (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); 전기수술 펜 (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)K162034OBS 전기수술 발생기 (모델: OBS-350A)

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