SLM-1ER,SLM-2ER,SLM-3ER
K号: K171877 · 2017-12-21
广告
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)
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。
K262637裂隙灯 SL-D4(类型:LED)Topcon CorporationK253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus 眼前部摄像头Medimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。
广告