BIO-C TEMP
K号: K180199 · 2019-01-04
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决定日期2019-01-04
产品代码KIF
咨询委员会DE
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决定实质等同
器械摘要
BIO-C TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K180199. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BIO-C TEMP?
BIO-C TEMP is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K180199.
When did BIO-C TEMP receive FDA 510(k) clearance?
BIO-C TEMP received FDA 510(k) clearance on 2019-01-04, under 510(k) number K180199.
Who is the listed applicant for BIO-C TEMP?
The FDA 510(k) record lists Angelus Industria DE Produtos Odontologicos S/A as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIO-C TEMP?
The FDA product code for BIO-C TEMP is KIF.
列明Angelus Industria DE Produtos Odontologicos S/A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：KIF）
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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