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FDA 510(k)

Cochlear® 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

K号: K231204 · 2023-08-18

申请人Cochlear
决定日期2023-08-18
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® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231204. 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® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App?

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Cochlear. The 510(k) number is K231204.

When did Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App receive FDA 510(k) clearance?

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231204.

Who is the listed applicant for Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App?

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

What is the FDA product code for Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App?

The FDA product code for Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App is PFO.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Cochlear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。

K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandK223672Instrument Case P1340904

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 AmericasK240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical ABK240155Cochlear Osia系统Cochlear AmericasK220922Cochlear 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 AmericasK201983BCI 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 GmbHK200504BONEBRIDGE系统，SAMBA 2 BB，SYMFIT 8.0，SAMBA 2 GO，SAMBA 2遥控器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。

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