Delphi Stimulator
K号: K242345 · 2024-11-05
广告
决定日期2024-11-05
产品代码GWF
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Delphi Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neuroscience. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K242345. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Delphi Stimulator?
Delphi Stimulator is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Quantalx Neuroscience. The 510(k) number is K242345.
When did Delphi Stimulator receive FDA 510(k) clearance?
Delphi Stimulator received FDA 510(k) clearance on 2024-11-05, under 510(k) number K242345.
Who is the listed applicant for Delphi Stimulator?
The FDA 510(k) record lists Quantalx Neuroscience as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Delphi Stimulator?
The FDA product code for Delphi Stimulator is GWF.
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：GWF）
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。
K263010ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3：Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK234092SafeOp 3：Neural Informatix SysteemAlphatec Spine, 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。
广告