Therapy EC，Therapy XT
K号: K232813 · 2024-12-19
广告
决定日期2024-12-19
产品代码NHN
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Therapy EC, Therapy XT is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K232813. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Therapy EC, Therapy XT?
Therapy EC, Therapy XT is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. The 510(k) number is K232813.
When did Therapy EC, Therapy XT receive FDA 510(k) clearance?
Therapy EC, Therapy XT received FDA 510(k) clearance on 2024-12-19, under 510(k) number K232813.
Who is the listed applicant for Therapy EC, Therapy XT?
The FDA 510(k) record lists Dmc Importacao E Exportacao DE Equipamentos Ltda as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Therapy EC, Therapy XT?
The FDA product code for Therapy EC, Therapy XT is NHN.
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：NHN）
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。
K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN 激光 (型号# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K231409Erchonia FX-405Erchonia CorporationK212189FibroLuxMulti Radiance Medical
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。
广告