MEGA-TMS
K号: K192823 · 2021-08-13
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决定日期2021-08-13
产品代码GWF
咨询委员会NE
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决定实质等同
器械摘要
MEGA-TMS is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K192823. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MEGA-TMS?
MEGA-TMS is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K192823.
When did MEGA-TMS receive FDA 510(k) clearance?
MEGA-TMS received FDA 510(k) clearance on 2021-08-13, under 510(k) number K192823.
Who is the listed applicant for MEGA-TMS?
The FDA 510(k) record lists Soterix Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MEGA-TMS?
The FDA product code for MEGA-TMS is GWF.
列明Soterix Medical, Inc.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：GWF）
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。
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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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