FDA 510(k)

SLM-1ER, SLM-2ER, SLM-3ER

K-번호: K171877 · 2017-12-21

신청자Chongqing Kanghua Ruiming S&T Co., Ltd.

결정일2017-12-21

제품 코드HJO

자문 위원회의료장비 규제 텍스트 번역 OP

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기기 요약

SLM-1ER, SLM-2ER, SLM-3ER is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Kanghua Ruiming S&T Co., Ltd.. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171877. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SLM-1ER, SLM-2ER, SLM-3ER?

SLM-1ER, SLM-2ER, SLM-3ER is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Chongqing Kanghua Ruiming S&T Co., Ltd.. The 510(k) number is K171877.

When did SLM-1ER, SLM-2ER, SLM-3ER receive FDA 510(k) clearance?

SLM-1ER, SLM-2ER, SLM-3ER received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171877.

Who is the listed applicant for SLM-1ER, SLM-2ER, SLM-3ER?

The FDA 510(k) record lists Chongqing Kanghua Ruiming S&T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLM-1ER, SLM-2ER, SLM-3ER?

The FDA product code for SLM-1ER, SLM-2ER, SLM-3ER is HJO.

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기기 요약

자주 묻는 질문

관련 기기 (코드: HJO)

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