Instrument Case
K号: K231604 · 2023-08-24
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决定日期2023-08-24
产品代码KCT
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
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器械摘要
Instrument Case is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K231604. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Instrument Case?
Instrument Case is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Cochlear Americas. The 510(k) number is K231604.
When did Instrument Case receive FDA 510(k) clearance?
Instrument Case received FDA 510(k) clearance on 2023-08-24, under 510(k) number K231604.
Who is the listed applicant for Instrument Case?
The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Instrument Case?
The FDA product code for Instrument Case is KCT.
相关临床试验
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。
列明Cochlear Americas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。
K260902Cochlear® Osia® 3(I)声音处理器；Cochlear® Osia® 3声音处理器；Cochlear® Osia® 3充电器；Cochlear® Osia® 3 Aqua+；Cochlear® Osia® 3适配软件；Cochlear® Osia®智能应用；Cochlear® Osia®系统K240155Cochlear Osia系统K220922Cochlear Osia 2系统，Cochlear Osia OSI200植入器，Cochlear Osia 2声音处理器，Cochlear Osia适配软件2，Cochlear MRI套件K212136Cochlear Baha 6系统，Cochlear Baha适配软件6，Cochlear Baha Baha智能应用K202048Cochlear Baha 6 Max声音处理器，Cochlear Baha适配软件6，Cochlear Baha智能应用K191921Cochlear Osia OSI200植入器，Cochlear Osia 2声音处理器，Osia适配软件2.0，Osia SmartApp，Cochlear Osia手术器械
相关器械（代码：KCT）
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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