MINE ALNU (型号：Mine 2.1)
K号: K213405 · 2022-07-10
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器械摘要
MINE ALNU (Model: Mine 2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Hdt Co., Ltd.. It received FDA 510(k) clearance on 2022-07-10 under 510(k) number K213405. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MINE ALNU (Model: Mine 2.1)?
MINE ALNU (Model: Mine 2.1) is a medical device that received FDA 510(k) clearance on 2022-07-10. The listed applicant is Hdt Co., Ltd.. The 510(k) number is K213405.
When did MINE ALNU (Model: Mine 2.1) receive FDA 510(k) clearance?
MINE ALNU (Model: Mine 2.1) received FDA 510(k) clearance on 2022-07-10, under 510(k) number K213405.
Who is the listed applicant for MINE ALNU (Model: Mine 2.1)?
The FDA 510(k) record lists Hdt Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MINE ALNU (Model: Mine 2.1)?
The FDA product code for MINE ALNU (Model: Mine 2.1) is IZL.
相关临床试验
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相关器械（代码：IZL）
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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