CIONIC 神经袖套 (NS-200)
K号: K243828 · 2025-05-02
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申请人Cionic, Inc.
决定日期2025-05-02
产品代码GZI
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
CIONIC NEURAL SLEEVE (NS-200) is the device name listed in this FDA 510(k) record. The listed applicant is Cionic, Inc.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K243828. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CIONIC NEURAL SLEEVE (NS-200)?
CIONIC NEURAL SLEEVE (NS-200) is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Cionic, Inc.. The 510(k) number is K243828.
When did CIONIC NEURAL SLEEVE (NS-200) receive FDA 510(k) clearance?
CIONIC NEURAL SLEEVE (NS-200) received FDA 510(k) clearance on 2025-05-02, under 510(k) number K243828.
Who is the listed applicant for CIONIC NEURAL SLEEVE (NS-200)?
The FDA 510(k) record lists Cionic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CIONIC NEURAL SLEEVE (NS-200)?
The FDA product code for CIONIC NEURAL SLEEVE (NS-200) is GZI.
相关临床试验
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相关器械（代码：GZI）
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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