Otowave 302便携式鼓室测压器
K号: K171265 · 2017-07-28
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决定日期2017-07-28
产品代码NAS
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
Otowave 302 Portable Tympanometer is the device name listed in this FDA 510(k) record. The listed applicant is Amplivox, Ltd.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K171265. The device is classified under product code NAS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Otowave 302 Portable Tympanometer?
Otowave 302 Portable Tympanometer is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Amplivox, Ltd.. The 510(k) number is K171265.
When did Otowave 302 Portable Tympanometer receive FDA 510(k) clearance?
Otowave 302 Portable Tympanometer received FDA 510(k) clearance on 2017-07-28, under 510(k) number K171265.
Who is the listed applicant for Otowave 302 Portable Tympanometer?
The FDA 510(k) record lists Amplivox, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Otowave 302 Portable Tympanometer?
The FDA product code for Otowave 302 Portable Tympanometer is NAS.
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。
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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