电动手持电机
K号: K181858 · 2019-03-26
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决定日期2019-03-26
产品代码EBW
咨询委员会DE
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决定实质等同
器械摘要
Electric Handpiece Motor is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K181858. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Electric Handpiece Motor?
Electric Handpiece Motor is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K181858.
When did Electric Handpiece Motor receive FDA 510(k) clearance?
Electric Handpiece Motor received FDA 510(k) clearance on 2019-03-26, under 510(k) number K181858.
Who is the listed applicant for Electric Handpiece Motor?
The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Handpiece Motor?
The FDA product code for Electric Handpiece Motor is EBW.
相关临床试验
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。
列明W&H Dentalwerk Buermoos GmbH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：EBW）
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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