SMD-Sr90-DA 放射性核素近距离放射治疗源
K号: K163206 · 2016-12-15
广告
器械摘要
SMD-Sr90-DA Radionuclide Brachytherapy Source is the device name listed in this FDA 510(k) record. The listed applicant is Salutaris Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K163206. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SMD-Sr90-DA Radionuclide Brachytherapy Source?
SMD-Sr90-DA Radionuclide Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Salutaris Medical Devices, Inc.. The 510(k) number is K163206.
When did SMD-Sr90-DA Radionuclide Brachytherapy Source receive FDA 510(k) clearance?
SMD-Sr90-DA Radionuclide Brachytherapy Source received FDA 510(k) clearance on 2016-12-15, under 510(k) number K163206.
Who is the listed applicant for SMD-Sr90-DA Radionuclide Brachytherapy Source?
The FDA 510(k) record lists Salutaris Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source?
The FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source is KXK.
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。
相关器械（代码：KXK）
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。
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