Erchonia EVRL
K号: K152196 · 2016-02-18
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决定日期2016-02-18
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 EVRL is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K152196. 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 EVRL?
Erchonia EVRL is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Erchonia Corporation. The 510(k) number is K152196.
When did Erchonia EVRL receive FDA 510(k) clearance?
Erchonia EVRL received FDA 510(k) clearance on 2016-02-18, under 510(k) number K152196.
Who is the listed applicant for Erchonia EVRL?
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 EVRL?
The FDA product code for Erchonia EVRL 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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