FDA 510(k)

Cochlear Osia OSI200植入器，Cochlear Osia 2声音处理器，Osia适配软件2.0，Osia SmartApp，Cochlear Osia手术器械

K号: K191921 · 2019-11-15

决定日期2019-11-15

产品代码PFO

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

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K191921. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments?

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Cochlear Americas. The 510(k) number is K191921.

When did Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments receive FDA 510(k) clearance?

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191921.

Who is the listed applicant for Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments?

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 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments?

The FDA product code for Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments is PFO.

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。

K260902Cochlear® Osia® 3(I)声音处理器；Cochlear® Osia® 3声音处理器；Cochlear® Osia® 3充电器；Cochlear® Osia® 3 Aqua+；Cochlear® Osia® 3适配软件；Cochlear® Osia®智能应用；Cochlear® Osia®系统 K240155Cochlear Osia系统 K231604Instrument Case K220922Cochlear Osia 2系统，Cochlear Osia OSI200植入器，Cochlear Osia 2声音处理器，Cochlear Osia适配软件2，Cochlear MRI套件 K212136Cochlear Baha 6系统，Cochlear Baha适配软件6，Cochlear Baha Baha智能应用 K202048Cochlear Baha 6 Max声音处理器，Cochlear Baha适配软件6，Cochlear Baha智能应用

查看所有 12 个设备 →

相关器械（代码：PFO）

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。

K260902Cochlear® Osia® 3(I)声音处理器；Cochlear® Osia® 3声音处理器；Cochlear® Osia® 3充电器；Cochlear® Osia® 3 Aqua+；Cochlear® Osia® 3适配软件；Cochlear® Osia®智能应用；Cochlear® Osia®系统Cochlear Americas K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical AB K240155Cochlear Osia系统Cochlear Americas K231204Cochlear® Osia®系统；Cochlear® Osia® OSI300植入器；Cochlear®磁带；Cochlear®非磁性磁带；Cochlear® Osia® 2(I)声音处理器；Cochlear® Osia®适配软件2；Cochlear® Osia®智能应用Cochlear K220922Cochlear Osia 2系统，Cochlear Osia OSI200植入器，Cochlear Osia 2声音处理器，Cochlear Osia适配软件2，Cochlear MRI套件Cochlear Americas K201983BCI 602 升降机（1毫米），BCI 升降机（1毫米），BCI 升降机（2毫米和3毫米），BCI 升降机（4毫米）Med-El Elektromedizinische Geraete GmbH

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。