ANNE 母亲
K号: K253021 · 2026-02-26
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决定日期2026-02-26
产品代码HGM
咨询委员会OB
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决定实质等同
器械摘要
ANNE Maternal is the device name listed in this FDA 510(k) record. The listed applicant is Sibel Health, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253021. 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 ANNE Maternal?
ANNE Maternal is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Sibel Health, Inc.. The 510(k) number is K253021.
When did ANNE Maternal receive FDA 510(k) clearance?
ANNE Maternal received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253021.
Who is the listed applicant for ANNE Maternal?
The FDA 510(k) record lists Sibel Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ANNE Maternal?
The FDA product code for ANNE Maternal 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Sibel Health, Inc.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.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.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。
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