FDA 510(k)

Ponto 5 SuperPower

K号: K213733 · 2021-12-16

决定日期2021-12-16

产品代码LXB

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

Ponto 5 SuperPower is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical AB. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213733. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ponto 5 SuperPower?

Ponto 5 SuperPower is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Oticon Medical AB. The 510(k) number is K213733.

When did Ponto 5 SuperPower receive FDA 510(k) clearance?

Ponto 5 SuperPower received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213733.

Who is the listed applicant for Ponto 5 SuperPower?

FDA 510(k)记录显示奥蒂康医疗AB为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Ponto 5 SuperPower?

The FDA product code for Ponto 5 SuperPower is LXB.

列明Oticon Medical AB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。

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相关器械（代码：LXB）

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。

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官方来源

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