Sontro® OTC 耳机 (AI)
K号: K231550 · 2023-10-26
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决定日期2023-10-26
产品代码QUH
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
Sontro® OTC Hearing Aids (AI) is the device name listed in this FDA 510(k) record. The listed applicant is Soundwave Hearing, LLC. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K231550. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sontro® OTC Hearing Aids (AI)?
Sontro® OTC Hearing Aids (AI) is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Soundwave Hearing, LLC. The 510(k) number is K231550.
When did Sontro® OTC Hearing Aids (AI) receive FDA 510(k) clearance?
Sontro® OTC Hearing Aids (AI) received FDA 510(k) clearance on 2023-10-26, under 510(k) number K231550.
Who is the listed applicant for Sontro® OTC Hearing Aids (AI)?
The FDA 510(k) record lists Soundwave Hearing, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sontro® OTC Hearing Aids (AI)?
The FDA product code for Sontro® OTC Hearing Aids (AI) is QUH.
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：QUH）
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。
K254108Jabra Enhance Select 自适应型（Jabra Enhance Select 550）GN Hearing A/SK233747Concha Sol 耳机（CL-1001）Concha LabsK233464WSA 自适应助听器第二代Wsaud A/SK221052自调适助听器Huizhou Jinghao Medical Technology Co., Ltd.K223848Intrisound™ 调谐光管® 155 听力辅助设备Tuned , Ltd.K230538All-Day Clear Slim ADCS1助听器。All-Day Clear ADC1助听器Sonova AG
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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