gammaCore-S
K号: K171306 · 2017-05-30
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决定日期2017-05-30
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-S is the device name listed in this FDA 510(k) record. The listed applicant is Electrocore, LLC. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K171306. 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-S?
gammaCore-S is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Electrocore, LLC. The 510(k) number is K171306.
When did gammaCore-S receive FDA 510(k) clearance?
gammaCore-S received FDA 510(k) clearance on 2017-05-30, under 510(k) number K171306.
Who is the listed applicant for gammaCore-S?
The FDA 510(k) record lists Electrocore, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for gammaCore-S?
The FDA product code for gammaCore-S is PKR.
相关临床试验
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列明Electrocore, LLC为申报人的其他记录
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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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