Sonicaid Team3
K号: K250777 · 2025-09-19
广告
决定日期2025-09-19
产品代码HGM
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Sonicaid Team3 is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250777. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sonicaid Team3?
Sonicaid Team3 is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K250777.
When did Sonicaid Team3 receive FDA 510(k) clearance?
Sonicaid Team3 received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250777.
Who is the listed applicant for Sonicaid Team3?
The FDA 510(k) record lists Huntleigh Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sonicaid Team3?
The FDA product code for Sonicaid Team3 is HGM.
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Huntleigh Healthcare , Ltd.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：HGM）
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。
K254036Novii+ 无线贴片系统Datex Ohmeda, Inc.K253021ANNE 母亲Sibel Health, Inc.K241882胎儿与母体监护仪（F15A，F15A Air）Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.K233440Avalon CL胎儿与母亲（F&M）Pod（866488），Avalon CL胎儿与母亲（F&M）贴片（989803196341）Philips Medizin Systeme Boeblingen 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。
广告