Smart Scope® CX
K号: K233043 · 2024-06-14
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决定日期2024-06-14
产品代码HEX
咨询委员会OB
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决定实质等同
器械摘要
Smart Scope® CX is the device name listed in this FDA 510(k) record. The listed applicant is Periwinkle Technologies Pvt., Ltd.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K233043. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Smart Scope® CX?
Smart Scope® CX is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Periwinkle Technologies Pvt., Ltd.. The 510(k) number is K233043.
When did Smart Scope® CX receive FDA 510(k) clearance?
Smart Scope® CX received FDA 510(k) clearance on 2024-06-14, under 510(k) number K233043.
Who is the listed applicant for Smart Scope® CX?
The FDA 510(k) record lists Periwinkle Technologies Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Smart Scope® CX?
The FDA product code for Smart Scope® CX is HEX.
相关临床试验
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相关器械（代码：HEX）
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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