Erchonia XLR8
K号: K211186 · 2021-10-22
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决定日期2021-10-22
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 XLR8 is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K211186. 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 XLR8?
Erchonia XLR8 is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Erchonia Corporation. The 510(k) number is K211186.
When did Erchonia XLR8 receive FDA 510(k) clearance?
Erchonia XLR8 received FDA 510(k) clearance on 2021-10-22, under 510(k) number K211186.
Who is the listed applicant for Erchonia XLR8?
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 XLR8?
The FDA product code for Erchonia XLR8 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
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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