Stella
K号: K221752 · 2023-06-04
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决定日期2023-06-04
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
Stella 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 2023-06-04 under 510(k) number K221752. 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 Stella?
Stella is a medical device that received FDA 510(k) clearance on 2023-06-04. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K221752.
When did Stella receive FDA 510(k) clearance?
Stella received FDA 510(k) clearance on 2023-06-04, under 510(k) number K221752.
Who is the listed applicant for Stella?
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 Stella?
The FDA product code for Stella is DZE.
相关临床试验
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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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