听力辅助设备
K号: K254044 · 2026-07-13
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决定日期2026-07-13
产品代码SCR
咨询委员会医疗设备监管文本描述翻译如下：
关于[公司/产品名称]的监管信息：
- 美国食品药品监督管理局（FDA）批准号：[510(k)编号]
- 预市场批准（PMA）申请号：[PMA编号]
- 临床试验注册号（NCT）：[NCT编号]
- 医学文献标识符（PMID）：[PMID编号]
- 产品标识符：[标识符]
- 相关政策：医疗监管政策v1
- 更多信息请访问：[URL]
请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。
决定实质等同
器械摘要
Hearing assist is the device name listed in this FDA 510(k) record. The listed applicant is Meta Platform Technologies, LLC. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K254044. The device is classified under product code SCR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hearing assist?
Hearing assist is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Meta Platform Technologies, LLC. The 510(k) number is K254044.
When did Hearing assist receive FDA 510(k) clearance?
Hearing assist received FDA 510(k) clearance on 2026-07-13, under 510(k) number K254044.
Who is the listed applicant for Hearing assist?
The FDA 510(k) record lists Meta Platform Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hearing assist?
The FDA product code for Hearing assist is SCR.
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：SCR）
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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