IGAR 系统 (1001.A)
K号: K223484 · 2023-07-20
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器械摘要
IGAR System (1001.A) is the device name listed in this FDA 510(k) record. The listed applicant is Insight Medbotics, Inc.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K223484. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IGAR System (1001.A)?
IGAR System (1001.A) is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Insight Medbotics, Inc.. The 510(k) number is K223484.
When did IGAR System (1001.A) receive FDA 510(k) clearance?
IGAR System (1001.A) received FDA 510(k) clearance on 2023-07-20, under 510(k) number K223484.
Who is the listed applicant for IGAR System (1001.A)?
The FDA 510(k) record lists Insight Medbotics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IGAR System (1001.A)?
The FDA product code for IGAR System (1001.A) is MOS.
相关临床试验
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相关器械（代码：MOS）
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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