gammaCore-2
K号: K172270 · 2017-12-07
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决定日期2017-12-07
产品代码PKR
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
gammaCore-2 is the device name listed in this FDA 510(k) record. The listed applicant is Eletrocore, LLC. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K172270. The device is classified under product code PKR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the gammaCore-2?
gammaCore-2 is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Eletrocore, LLC. The 510(k) number is K172270.
When did gammaCore-2 receive FDA 510(k) clearance?
gammaCore-2 received FDA 510(k) clearance on 2017-12-07, under 510(k) number K172270.
Who is the listed applicant for gammaCore-2?
The FDA 510(k) record lists Eletrocore, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for gammaCore-2?
The FDA product code for gammaCore-2 is PKR.
相关临床试验
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相关器械（代码：PKR）
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。
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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