FDA 510(k)

전도성 실리콘 루브 전극

K-번호: K231167 · 2023-08-09

결정일2023-08-09

제품 코드GXY

자문 위원회NE

결정Substantially Equivalent

기기 요약

Conductive Silicone Rubber Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K231167. 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 Conductive Silicone Rubber Electrode?

Conductive Silicone Rubber Electrode is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K231167.

When did Conductive Silicone Rubber Electrode receive FDA 510(k) clearance?

Conductive Silicone Rubber Electrode received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231167.

Who is the listed applicant for Conductive Silicone Rubber Electrode?

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

What is the FDA product code for Conductive Silicone Rubber Electrode?

The FDA product code for Conductive Silicone Rubber Electrode is GXY.

Guangzhou Xinbo Electronic Co., Ltd.를 신청인으로 등재한 기타 기록

K230711Pain Therapy Device(Model: P.T.S-X)K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)K231164전도성 탄소필름 전극 K202671DR-HO의 뒷목 통증 완화 시스템 프로(모델 BPRS-I와 BPRS-II)K212948Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)K202636Metallic Fabric Electrodes

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