Erchonia FX-635
K号: K180197 · 2018-05-21
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决定日期2018-05-21
产品代码NHN
咨询委员会PM
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决定实质等同
器械摘要
Erchonia FX-635 is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K180197. 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 Erchonia FX-635?
Erchonia FX-635 is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Erchonia Corporation. The 510(k) number is K180197.
When did Erchonia FX-635 receive FDA 510(k) clearance?
Erchonia FX-635 received FDA 510(k) clearance on 2018-05-21, under 510(k) number K180197.
Who is the listed applicant for Erchonia FX-635?
The FDA 510(k) record lists Erchonia Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Erchonia FX-635?
The FDA product code for Erchonia FX-635 is NHN.
相关临床试验
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列明Erchonia Corporation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：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..K232813Therapy EC，Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation
官方来源
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