裂隙灯 SL-2000
K号: K163564 · 2017-05-19
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决定日期2017-05-19
产品代码HJO
咨询委员会OP
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决定实质等同
器械摘要
SLIT LAMP SL-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K163564. 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 SLIT LAMP SL-2000?
SLIT LAMP SL-2000 is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K163564.
When did SLIT LAMP SL-2000 receive FDA 510(k) clearance?
SLIT LAMP SL-2000 received FDA 510(k) clearance on 2017-05-19, under 510(k) number K163564.
Who is the listed applicant for SLIT LAMP SL-2000?
The FDA 510(k) record lists Nidek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SLIT LAMP SL-2000?
The FDA product code for SLIT LAMP SL-2000 is HJO.
列明Nidek Co., Ltd.为申报人的其他记录
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。
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。
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