KOWA DR-1a
K号: K190573 · 2019-06-04
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决定日期2019-06-04
产品代码HKI
咨询委员会OP
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决定实质等同
器械摘要
KOWA DR-1a is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Company , Ltd.. It received FDA 510(k) clearance on 2019-06-04 under 510(k) number K190573. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the KOWA DR-1a?
KOWA DR-1a is a medical device that received FDA 510(k) clearance on 2019-06-04. The listed applicant is Kowa Company , Ltd.. The 510(k) number is K190573.
When did KOWA DR-1a receive FDA 510(k) clearance?
KOWA DR-1a received FDA 510(k) clearance on 2019-06-04, under 510(k) number K190573.
Who is the listed applicant for KOWA DR-1a?
The FDA 510(k) record lists Kowa Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KOWA DR-1a?
The FDA product code for KOWA DR-1a is HKI.
列明Kowa Company , 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：HKI）
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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