P50系列牙科手术单元及附件
K号: K171872 · 2018-04-26
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决定日期2018-04-26
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
P50 Series Dental Operative Unit and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane. It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K171872. 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 P50 Series Dental Operative Unit and Accessories?
P50 Series Dental Operative Unit and Accessories is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is Pelton & Crane. The 510(k) number is K171872.
When did P50 Series Dental Operative Unit and Accessories receive FDA 510(k) clearance?
P50 Series Dental Operative Unit and Accessories received FDA 510(k) clearance on 2018-04-26, under 510(k) number K171872.
Who is the listed applicant for P50 Series Dental Operative Unit and Accessories?
The FDA 510(k) record lists Pelton & Crane as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for P50 Series Dental Operative Unit and Accessories?
The FDA product code for P50 Series Dental Operative Unit and Accessories is EIA.
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。
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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