NeoGen PSR 系统
K号: K221873 · 2023-01-12
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器械摘要
NeoGen PSR System is the device name listed in this FDA 510(k) record. The listed applicant is Energist Limited. It received FDA 510(k) clearance on 2023-01-12 under 510(k) number K221873. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NeoGen PSR System?
NeoGen PSR System is a medical device that received FDA 510(k) clearance on 2023-01-12. The listed applicant is Energist Limited. The 510(k) number is K221873.
When did NeoGen PSR System receive FDA 510(k) clearance?
NeoGen PSR System received FDA 510(k) clearance on 2023-01-12, under 510(k) number K221873.
Who is the listed applicant for NeoGen PSR System?
The FDA 510(k) record lists Energist Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeoGen PSR System?
The FDA product code for NeoGen PSR System is GEI.
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：GEI）
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。
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官方来源
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