Fit SA
K号: K182869 · 2019-01-09
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决定日期2019-01-09
产品代码EBF
咨询委员会DE
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决定实质等同
器械摘要
Fit SA is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K182869. 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 Fit SA?
Fit SA is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Shofu Dental Corporation. The 510(k) number is K182869.
When did Fit SA receive FDA 510(k) clearance?
Fit SA received FDA 510(k) clearance on 2019-01-09, under 510(k) number K182869.
Who is the listed applicant for Fit SA?
The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fit SA?
The FDA product code for Fit SA is EBF.
列明Shofu Dental Corporation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：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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