SACCADOMETER PLUS, SACCADOMETER ADVANCED
K号: K152890 · 2016-08-11
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决定日期2016-08-11
产品代码HLL
咨询委员会OP
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决定实质等同
器械摘要
SACCADOMETER PLUS, SACCADOMETER ADVANCED is the device name listed in this FDA 510(k) record. The listed applicant is Ober Consulting Sp. Z.O.O.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K152890. The device is classified under product code HLL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SACCADOMETER PLUS, SACCADOMETER ADVANCED?
SACCADOMETER PLUS, SACCADOMETER ADVANCED is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Ober Consulting Sp. Z.O.O.. The 510(k) number is K152890.
When did SACCADOMETER PLUS, SACCADOMETER ADVANCED receive FDA 510(k) clearance?
SACCADOMETER PLUS, SACCADOMETER ADVANCED received FDA 510(k) clearance on 2016-08-11, under 510(k) number K152890.
Who is the listed applicant for SACCADOMETER PLUS, SACCADOMETER ADVANCED?
The FDA 510(k) record lists Ober Consulting Sp. Z.O.O. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SACCADOMETER PLUS, SACCADOMETER ADVANCED?
The FDA product code for SACCADOMETER PLUS, SACCADOMETER ADVANCED is HLL.
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相关器械（代码：HLL）
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。
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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