CORE-SNARE
K号: K220846 · 2022-11-21
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决定日期2022-11-21
产品代码FDI
咨询委员会GU
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决定实质等同
器械摘要
CORE-SNARE is the device name listed in this FDA 510(k) record. The listed applicant is Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K220846. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CORE-SNARE?
CORE-SNARE is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Incore Co., Ltd.. The 510(k) number is K220846.
When did CORE-SNARE receive FDA 510(k) clearance?
CORE-SNARE received FDA 510(k) clearance on 2022-11-21, under 510(k) number K220846.
Who is the listed applicant for CORE-SNARE?
The FDA 510(k) record lists Incore Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CORE-SNARE?
The FDA product code for CORE-SNARE is FDI.
相关临床试验
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列明Incore Co., Ltd.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：FDI）
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
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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