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FDA 510(k)

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

K号: K171877 · 2017-12-21

决定日期2017-12-21
产品代码HJO
咨询委员会OP 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关器械(代码:HJO)

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