智慧皮层条（WCS）
K号: K221123 · 2022-11-22
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申请人Wise S.R.L.
决定日期2022-11-22
产品代码GYC
咨询委员会NE
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决定实质等同
器械摘要
WISE Cortical Strip (WCS) is the device name listed in this FDA 510(k) record. The listed applicant is Wise S.R.L.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221123. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the WISE Cortical Strip (WCS)?
WISE Cortical Strip (WCS) is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Wise S.R.L.. The 510(k) number is K221123.
When did WISE Cortical Strip (WCS) receive FDA 510(k) clearance?
WISE Cortical Strip (WCS) received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221123.
Who is the listed applicant for WISE Cortical Strip (WCS)?
The FDA 510(k) record lists Wise S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WISE Cortical Strip (WCS)?
The FDA product code for WISE Cortical Strip (WCS) is GYC.
相关临床试验
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：GYC）
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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