EndyMed Contour 手柄
K号: K161199 · 2016-08-01
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决定日期2016-08-01
产品代码PBX
咨询委员会SU
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器械摘要
EndyMed Contour Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K161199. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EndyMed Contour Handpiece?
EndyMed Contour Handpiece is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Endymed Medical, Ltd.. The 510(k) number is K161199.
When did EndyMed Contour Handpiece receive FDA 510(k) clearance?
EndyMed Contour Handpiece received FDA 510(k) clearance on 2016-08-01, under 510(k) number K161199.
Who is the listed applicant for EndyMed Contour Handpiece?
The FDA 510(k) record lists Endymed Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EndyMed Contour Handpiece?
The FDA product code for EndyMed Contour Handpiece is PBX.
相关临床试验
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列明Endymed Medical, Ltd.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：PBX）
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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