DVAS (DVAS-M, DVAS-W)
K号: K232085 · 2023-12-08
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决定日期2023-12-08
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
DVAS (DVAS-M, DVAS-W) is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K232085. 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 DVAS (DVAS-M, DVAS-W)?
DVAS (DVAS-M, DVAS-W) is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K232085.
When did DVAS (DVAS-M, DVAS-W) receive FDA 510(k) clearance?
DVAS (DVAS-M, DVAS-W) received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232085.
Who is the listed applicant for DVAS (DVAS-M, DVAS-W)?
The FDA 510(k) record lists Genoray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DVAS (DVAS-M, DVAS-W)?
The FDA product code for DVAS (DVAS-M, DVAS-W) is EHD.
列明Genoray 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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