Magseed磁标记系统
K号: K163541 · 2017-01-13
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决定日期2017-01-13
产品代码PBY
咨询委员会SU
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决定实质等同
器械摘要
Magseed Magnetic Marker System is the device name listed in this FDA 510(k) record. The listed applicant is Endomagnetics Ltd.,. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K163541. The device is classified under product code PBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Magseed Magnetic Marker System?
Magseed Magnetic Marker System is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Endomagnetics Ltd.,. The 510(k) number is K163541.
When did Magseed Magnetic Marker System receive FDA 510(k) clearance?
Magseed Magnetic Marker System received FDA 510(k) clearance on 2017-01-13, under 510(k) number K163541.
Who is the listed applicant for Magseed Magnetic Marker System?
The FDA 510(k) record lists Endomagnetics Ltd., as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Magseed Magnetic Marker System?
The FDA product code for Magseed Magnetic Marker System is PBY.
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Endomagnetics 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：PBY）
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。
K223682Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K222643Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K200734Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K163667RFID定位系统-定位器读取器，RFID定位系统-定位器手术探头，RFID定位系统-定位器手术探头（5件装），RFID定位系统-标签应用器，RFID定位系统 -标签应用器（10件装）Health Beacons, Inc.K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,
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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