DHX-70H，XTG-70H
K号: K221587 · 2023-03-03
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决定日期2023-03-03
产品代码EHD
咨询委员会DE
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决定实质等同
器械摘要
DHX-70H, XTG-70H is the device name listed in this FDA 510(k) record. The listed applicant is Digimed Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K221587. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DHX-70H, XTG-70H?
DHX-70H, XTG-70H is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Digimed Co., Ltd.. The 510(k) number is K221587.
When did DHX-70H, XTG-70H receive FDA 510(k) clearance?
DHX-70H, XTG-70H received FDA 510(k) clearance on 2023-03-03, under 510(k) number K221587.
Who is the listed applicant for DHX-70H, XTG-70H?
The FDA 510(k) record lists Digimed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DHX-70H, XTG-70H?
The FDA product code for DHX-70H, XTG-70H is EHD.
列明Digimed 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：EHD）
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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