Firstar 牙科单元
K号: K231297 · 2025-01-27
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决定日期2025-01-27
产品代码EIA
咨询委员会DE
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决定实质等同
器械摘要
Firstar Dental Unit is the device name listed in this FDA 510(k) record. The listed applicant is Firstar Dental Company. It received FDA 510(k) clearance on 2025-01-27 under 510(k) number K231297. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Firstar Dental Unit?
Firstar Dental Unit is a medical device that received FDA 510(k) clearance on 2025-01-27. The listed applicant is Firstar Dental Company. The 510(k) number is K231297.
When did Firstar Dental Unit receive FDA 510(k) clearance?
Firstar Dental Unit received FDA 510(k) clearance on 2025-01-27, under 510(k) number K231297.
Who is the listed applicant for Firstar Dental Unit?
The FDA 510(k) record lists Firstar Dental Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Firstar Dental Unit?
The FDA product code for Firstar Dental Unit is EIA.
相关临床试验
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相关器械（代码：EIA）
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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