SURGmatic S15 L Pro
K号: K213139 · 2021-12-21
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决定日期2021-12-21
产品代码EGS
咨询委员会DE
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决定实质等同
器械摘要
SURGmatic S15 L Pro is the device name listed in this FDA 510(k) record. The listed applicant is Kavo Dental GmbH. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K213139. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SURGmatic S15 L Pro?
SURGmatic S15 L Pro is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Kavo Dental GmbH. The 510(k) number is K213139.
When did SURGmatic S15 L Pro receive FDA 510(k) clearance?
SURGmatic S15 L Pro received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213139.
Who is the listed applicant for SURGmatic S15 L Pro?
The FDA 510(k) record lists Kavo Dental GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SURGmatic S15 L Pro?
The FDA product code for SURGmatic S15 L Pro is EGS.
相关临床试验
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相关器械（代码：EGS）
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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