XChange 设备，XChange 系统
K号: K210112 · 2023-01-30
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决定日期2023-01-30
产品代码CCK
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
XChange Device, XChange System is the device name listed in this FDA 510(k) record. The listed applicant is Pneuma Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-30 under 510(k) number K210112. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XChange Device, XChange System?
XChange Device, XChange System is a medical device that received FDA 510(k) clearance on 2023-01-30. The listed applicant is Pneuma Therapeutics, Inc.. The 510(k) number is K210112.
When did XChange Device, XChange System receive FDA 510(k) clearance?
XChange Device, XChange System received FDA 510(k) clearance on 2023-01-30, under 510(k) number K210112.
Who is the listed applicant for XChange Device, XChange System?
The FDA 510(k) record lists Pneuma Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XChange Device, XChange System?
The FDA product code for XChange Device, XChange System is CCK.
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。
相关器械（代码：CCK）
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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