Duet外部引流和监测系统（EDMS）
K号: K242034 · 2024-10-24
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决定日期2024-10-24
产品代码PCB
咨询委员会NE
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器械摘要
Duet External Drainage and Monitoring System (EDMS) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K242034. The device is classified under product code PCB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Duet External Drainage and Monitoring System (EDMS)?
Duet External Drainage and Monitoring System (EDMS) is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K242034.
When did Duet External Drainage and Monitoring System (EDMS) receive FDA 510(k) clearance?
Duet External Drainage and Monitoring System (EDMS) received FDA 510(k) clearance on 2024-10-24, under 510(k) number K242034.
Who is the listed applicant for Duet External Drainage and Monitoring System (EDMS)?
The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Duet External Drainage and Monitoring System (EDMS)?
The FDA product code for Duet External Drainage and Monitoring System (EDMS) is PCB.
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列明Medtronic Neurosurgery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。
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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