DB-CMF
K号: K182742 · 2019-06-20
广告
决定日期2019-06-20
产品代码GXP
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
DB-CMF is the device name listed in this FDA 510(k) record. The listed applicant is Dimensional Bioceramics, LLC. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K182742. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DB-CMF?
DB-CMF is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Dimensional Bioceramics, LLC. The 510(k) number is K182742.
When did DB-CMF receive FDA 510(k) clearance?
DB-CMF received FDA 510(k) clearance on 2019-06-20, under 510(k) number K182742.
Who is the listed applicant for DB-CMF?
The FDA 510(k) record lists Dimensional Bioceramics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DB-CMF?
The FDA product code for DB-CMF is GXP.
列明Dimensional Bioceramics, 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：GXP）
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。
广告