Charisma
K号: K160049 · 2016-11-15
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决定日期2016-11-15
产品代码EBF
咨询委员会DE
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器械摘要
Charisma is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC (Mitsui Chemicals Group). It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K160049. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Charisma?
Charisma is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Heraeus Kulzer, LLC (Mitsui Chemicals Group). The 510(k) number is K160049.
When did Charisma receive FDA 510(k) clearance?
Charisma received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160049.
Who is the listed applicant for Charisma?
The FDA 510(k) record lists Heraeus Kulzer, LLC (Mitsui Chemicals Group) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Charisma?
The FDA product code for Charisma is EBF.
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相关器械（代码：EBF）
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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