K-ASSAY（R）RF（版本2），K-ASSAY（R）RF校准器（版本2）
K号: K192727 · 2020-05-20
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决定日期2020-05-20
产品代码DHR
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决定实质等同
器械摘要
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Company. It received FDA 510(k) clearance on 2020-05-20 under 510(k) number K192727. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is a medical device that received FDA 510(k) clearance on 2020-05-20. The listed applicant is Kamiya Biomedical Company. The 510(k) number is K192727.
When did K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) receive FDA 510(k) clearance?
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) received FDA 510(k) clearance on 2020-05-20, under 510(k) number K192727.
Who is the listed applicant for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?
The FDA 510(k) record lists Kamiya Biomedical Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?
The FDA product code for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is DHR.
相关临床试验
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相关器械（代码：DHR）
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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