LT-300 HD
K号: K160380 · 2016-05-13
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决定日期2016-05-13
产品代码HEX
咨询委员会OB
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决定实质等同
器械摘要
LT-300 HD is the device name listed in this FDA 510(k) record. The listed applicant is Lutech Industries, Inc.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K160380. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LT-300 HD?
LT-300 HD is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Lutech Industries, Inc.. The 510(k) number is K160380.
When did LT-300 HD receive FDA 510(k) clearance?
LT-300 HD received FDA 510(k) clearance on 2016-05-13, under 510(k) number K160380.
Who is the listed applicant for LT-300 HD?
The FDA 510(k) record lists Lutech Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LT-300 HD?
The FDA product code for LT-300 HD is HEX.
列明Lutech Industries, Inc.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：HEX）
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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