OmniTom Elite
K号: K233767 · 2024-06-10
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器械摘要
OmniTom Elite is the device name listed in this FDA 510(k) record. The listed applicant is Neurologica Corporation. It received FDA 510(k) clearance on 2024-06-10 under 510(k) number K233767. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OmniTom Elite?
OmniTom Elite is a medical device that received FDA 510(k) clearance on 2024-06-10. The listed applicant is Neurologica Corporation. The 510(k) number is K233767.
When did OmniTom Elite receive FDA 510(k) clearance?
OmniTom Elite received FDA 510(k) clearance on 2024-06-10, under 510(k) number K233767.
Who is the listed applicant for OmniTom Elite?
The FDA 510(k) record lists Neurologica Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OmniTom Elite?
The FDA product code for OmniTom Elite is JAK.
相关临床试验
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列明Neurologica Corporation为申报人的其他记录
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相关器械（代码：JAK）
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。
K261125BodyTom 64（NL4100）；OmniTom Elite（NL5000）Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 视觉阶段 6.0Fujifilm CorporationK253836FCT iStream 阶段 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ 套件GE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC
官方来源
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