Pulsaderm ACE-All Blue
K号: K162371 · 2016-12-15
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决定日期2016-12-15
产品代码OLP
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Pulsaderm ACE-All Blue is the device name listed in this FDA 510(k) record. The listed applicant is Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K162371. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pulsaderm ACE-All Blue?
Pulsaderm ACE-All Blue is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Nutra Luxe MD, LLC. The 510(k) number is K162371.
When did Pulsaderm ACE-All Blue receive FDA 510(k) clearance?
Pulsaderm ACE-All Blue received FDA 510(k) clearance on 2016-12-15, under 510(k) number K162371.
Who is the listed applicant for Pulsaderm ACE-All Blue?
The FDA 510(k) record lists Nutra Luxe MD, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pulsaderm ACE-All Blue?
The FDA product code for Pulsaderm ACE-All Blue is OLP.
相关临床试验
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。
列明Nutra Luxe MD, LLC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：OLP）
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
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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