OtoNova/OtoNova Pro
K号: K234095 · 2024-06-21
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申请人Otodynamics
决定日期2024-06-21
产品代码EWO
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
OtoNova/OtoNova Pro is the device name listed in this FDA 510(k) record. The listed applicant is Otodynamics. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K234095. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OtoNova/OtoNova Pro?
OtoNova/OtoNova Pro is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Otodynamics. The 510(k) number is K234095.
When did OtoNova/OtoNova Pro receive FDA 510(k) clearance?
OtoNova/OtoNova Pro received FDA 510(k) clearance on 2024-06-21, under 510(k) number K234095.
Who is the listed applicant for OtoNova/OtoNova Pro?
The FDA 510(k) record lists Otodynamics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OtoNova/OtoNova Pro?
The FDA product code for OtoNova/OtoNova Pro is EWO.
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：EWO）
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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