Synexis Sphere Rx
K号: K221540 · 2023-06-14
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申请人Synexis, LLC
决定日期2023-06-14
产品代码FRA
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
Synexis Sphere Rx is the device name listed in this FDA 510(k) record. The listed applicant is Synexis, LLC. It received FDA 510(k) clearance on 2023-06-14 under 510(k) number K221540. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Synexis Sphere Rx?
Synexis Sphere Rx is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Synexis, LLC. The 510(k) number is K221540.
When did Synexis Sphere Rx receive FDA 510(k) clearance?
Synexis Sphere Rx received FDA 510(k) clearance on 2023-06-14, under 510(k) number K221540.
Who is the listed applicant for Synexis Sphere Rx?
The FDA 510(k) record lists Synexis, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Synexis Sphere Rx?
The FDA product code for Synexis Sphere Rx is FRA.
相关临床试验
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相关器械（代码：FRA）
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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