设备名称:Bright
K号: K161849 · 2016-07-29
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决定日期2016-07-29
产品代码OHS
咨询委员会SU
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决定实质等同
器械摘要
Bright is the device name listed in this FDA 510(k) record. The listed applicant is Tanda Beauty Canada, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161849. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bright?
Bright is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Tanda Beauty Canada, Inc.. The 510(k) number is K161849.
When did Bright receive FDA 510(k) clearance?
Bright received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161849.
Who is the listed applicant for Bright?
The FDA 510(k) record lists Tanda Beauty Canada, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bright?
The FDA product code for Bright is OHS.
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相关器械(代码:OHS)
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。
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官方来源
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