ImmersiveView 手术计划 (IVSP®)
K号: K181813 · 2020-06-09
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决定日期2020-06-09
产品代码DZJ
咨询委员会DE
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决定实质等同
器械摘要
ImmersiveView Surgical Plan (IVSP®) is the device name listed in this FDA 510(k) record. The listed applicant is Immersivetouch. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K181813. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ImmersiveView Surgical Plan (IVSP®)?
ImmersiveView Surgical Plan (IVSP®) is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Immersivetouch. The 510(k) number is K181813.
When did ImmersiveView Surgical Plan (IVSP®) receive FDA 510(k) clearance?
ImmersiveView Surgical Plan (IVSP®) received FDA 510(k) clearance on 2020-06-09, under 510(k) number K181813.
Who is the listed applicant for ImmersiveView Surgical Plan (IVSP®)?
The FDA 510(k) record lists Immersivetouch as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ImmersiveView Surgical Plan (IVSP®)?
The FDA product code for ImmersiveView Surgical Plan (IVSP®) is DZJ.
相关临床试验
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列明Immersivetouch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。
相关器械（代码：DZJ）
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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