自形成磁铁（FLEX SFM）
K号: K243213 · 2025-01-29
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器械摘要
Self-Forming Magnet (FLEX SFM) is the device name listed in this FDA 510(k) record. The listed applicant is GI Windows, Inc.. It received FDA 510(k) clearance on 2025-01-29 under 510(k) number K243213. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Self-Forming Magnet (FLEX SFM)?
Self-Forming Magnet (FLEX SFM) is a medical device that received FDA 510(k) clearance on 2025-01-29. The listed applicant is GI Windows, Inc.. The 510(k) number is K243213.
When did Self-Forming Magnet (FLEX SFM) receive FDA 510(k) clearance?
Self-Forming Magnet (FLEX SFM) received FDA 510(k) clearance on 2025-01-29, under 510(k) number K243213.
Who is the listed applicant for Self-Forming Magnet (FLEX SFM)?
The FDA 510(k) record lists GI Windows, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-Forming Magnet (FLEX SFM)?
The FDA product code for Self-Forming Magnet (FLEX SFM) is SAH.
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GI Windows, 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：SAH）
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。
K261467GT 代谢磁系统（MAG-04，DS-01）（MAG-05，DS-01）Gt Metabolic Solutions, Inc.K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc.K253550自形成磁铁（Flexagon Plus OTOLoc）GI Windows, Inc.K250541自形成磁铁（Flexagon Plus OTOLoc）GI Windows, Inc.K243482自形成磁铁（Flexagon）GI Windows, Inc.K243359MagDI系统（MAG-02, DS-01）Gt Metabolic Solutions, Inc.
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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