BodyTom 64
K号: K213649 · 2022-04-29
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器械摘要
BodyTom 64 is the device name listed in this FDA 510(k) record. The listed applicant is Neurologica Corporation. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K213649. 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 BodyTom 64?
BodyTom 64 is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Neurologica Corporation. The 510(k) number is K213649.
When did BodyTom 64 receive FDA 510(k) clearance?
BodyTom 64 received FDA 510(k) clearance on 2022-04-29, under 510(k) number K213649.
Who is the listed applicant for BodyTom 64?
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 BodyTom 64?
The FDA product code for BodyTom 64 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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