S-Mono
K号: K221317 · 2023-01-13
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决定日期2023-01-13
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
S-Mono is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221317. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the S-Mono?
S-Mono is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K221317.
When did S-Mono receive FDA 510(k) clearance?
S-Mono received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221317.
Who is the listed applicant for S-Mono?
The FDA 510(k) record lists Shinhung Mst Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for S-Mono?
The FDA product code for S-Mono is DZE.
列明Shinhung Mst 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：DZE）
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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