FDA 510(k)

BA310 基台，BIA310 种植体/基台

K号: K182116 · 2018-12-19

决定日期2018-12-19

产品代码MAH

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

BA310 Abutment, BIA310 Implant/Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2018-12-19 under 510(k) number K182116. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BA310 Abutment, BIA310 Implant/Abutment?

BA310 Abutment, BIA310 Implant/Abutment is a medical device that received FDA 510(k) clearance on 2018-12-19. The listed applicant is Cochlear Americas. The 510(k) number is K182116.

When did BA310 Abutment, BIA310 Implant/Abutment receive FDA 510(k) clearance?

BA310 Abutment, BIA310 Implant/Abutment received FDA 510(k) clearance on 2018-12-19, under 510(k) number K182116.

Who is the listed applicant for BA310 Abutment, BIA310 Implant/Abutment?

The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BA310 Abutment, BIA310 Implant/Abutment?

The FDA product code for BA310 Abutment, BIA310 Implant/Abutment is MAH.

列明Cochlear Americas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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