WSA 自适应助听器第二代
K号: K233464 · 2024-02-09
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申请人Wsaud A/S
决定日期2024-02-09
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
WSA Self-Fitting Hearing Aid Gen 2 is the device name listed in this FDA 510(k) record. The listed applicant is Wsaud A/S. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K233464. 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 WSA Self-Fitting Hearing Aid Gen 2?
WSA Self-Fitting Hearing Aid Gen 2 is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Wsaud A/S. The 510(k) number is K233464.
When did WSA Self-Fitting Hearing Aid Gen 2 receive FDA 510(k) clearance?
WSA Self-Fitting Hearing Aid Gen 2 received FDA 510(k) clearance on 2024-02-09, under 510(k) number K233464.
Who is the listed applicant for WSA Self-Fitting Hearing Aid Gen 2?
The FDA 510(k) record lists Wsaud A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WSA Self-Fitting Hearing Aid Gen 2?
The FDA product code for WSA Self-Fitting Hearing Aid Gen 2 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。
列明Wsaud A/S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。
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 LabsK231550Sontro® OTC 耳机 (AI)Soundwave Hearing, LLCK221052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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