Ponto 3，Ponto 3 Power 和 Ponto 3 SuperPower
K号: K161671 · 2016-09-29
广告
决定日期2016-09-29
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 3, Ponto 3 Power and Ponto 3 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 2016-09-29 under 510(k) number K161671. 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 3, Ponto 3 Power and Ponto 3 SuperPower?
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Oticon Medical AB. The 510(k) number is K161671.
When did Ponto 3, Ponto 3 Power and Ponto 3 SuperPower receive FDA 510(k) clearance?
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower received FDA 510(k) clearance on 2016-09-29, under 510(k) number K161671.
Who is the listed applicant for Ponto 3, Ponto 3 Power and Ponto 3 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 3, Ponto 3 Power and Ponto 3 SuperPower?
The FDA product code for Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is LXB.
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。
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。
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。
K253431骨传导助听器（BM100、BM300、BM310、SHOKZHEAR BM400、SHOKZ BM400MN、SHOKZHEAR BM410、SHOKZHEAR BM410MN、SHOKZHEAR BM420和SHOKZHEAR BM420MN）Shokz Health Global LimitedK254296Ossiclear（Ossiclear 系统）SounductK260452骨传导助听器 (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)Zdeer Technology (Henan) Co., Ltd.K261256骨传导助听器 (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd.K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandCochlearK243041联系强特AlphaBhm-Tech Produktionsgesellschaft Mbh
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。
广告