FDA 510(k)

대한 일회용 CUP 전극

K-번호: K180232 · 2019-04-03

결정일2019-04-03

제품 코드GXY

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

결정Substantially Equivalent

기기 요약

DAEHAN Disposable CUP Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Daehan Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2019-04-03 under 510(k) number K180232. 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 DAEHAN Disposable CUP Electrodes?

DAEHAN Disposable CUP Electrodes is a medical device that received FDA 510(k) clearance on 2019-04-03. The listed applicant is Daehan Medical Systems Co., Ltd.. The 510(k) number is K180232.

When did DAEHAN Disposable CUP Electrodes receive FDA 510(k) clearance?

DAEHAN Disposable CUP Electrodes received FDA 510(k) clearance on 2019-04-03, under 510(k) number K180232.

Who is the listed applicant for DAEHAN Disposable CUP Electrodes?

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

What is the FDA product code for DAEHAN Disposable CUP Electrodes?

The FDA product code for DAEHAN Disposable CUP Electrodes is GXY.

Daehan Medical Systems Co., Ltd.를 신청인으로 등재한 기타 기록

K180247대한 접착면 전극 K161566DMS 일회용 피하 주사 전극

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