ControlSeal 电极 (ELSB)
K号: K223605 · 2022-12-30
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申请人Coapt
决定日期2022-12-30
产品代码GXY
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
ControlSeal Electrode (ELSB) is the device name listed in this FDA 510(k) record. The listed applicant is Coapt. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K223605. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ControlSeal Electrode (ELSB)?
ControlSeal Electrode (ELSB) is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Coapt. The 510(k) number is K223605.
When did ControlSeal Electrode (ELSB) receive FDA 510(k) clearance?
ControlSeal Electrode (ELSB) received FDA 510(k) clearance on 2022-12-30, under 510(k) number K223605.
Who is the listed applicant for ControlSeal Electrode (ELSB)?
The FDA 510(k) record lists Coapt as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ControlSeal Electrode (ELSB)?
The FDA product code for ControlSeal Electrode (ELSB) is GXY.
相关临床试验
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列明Coapt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：GXY）
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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