ANDI 2.2
K号: K261405 · 2026-05-28
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器械摘要
ANDI 2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Imeka Solutions, Inc.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K261405. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ANDI 2.2?
ANDI 2.2 is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Imeka Solutions, Inc.. The 510(k) number is K261405.
When did ANDI 2.2 receive FDA 510(k) clearance?
ANDI 2.2 received FDA 510(k) clearance on 2026-05-28, under 510(k) number K261405.
Who is the listed applicant for ANDI 2.2?
The FDA 510(k) record lists Imeka Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ANDI 2.2?
The FDA product code for ANDI 2.2 is QIH.
列明Imeka Solutions, Inc.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：QIH）
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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