SUPRIA 带guideShot 选项
K号: K161748 · 2016-08-17
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器械摘要
SUPRIA w/guideShot Option is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K161748. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SUPRIA w/guideShot Option?
SUPRIA w/guideShot Option is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K161748.
When did SUPRIA w/guideShot Option receive FDA 510(k) clearance?
SUPRIA w/guideShot Option received FDA 510(k) clearance on 2016-08-17, under 510(k) number K161748.
Who is the listed applicant for SUPRIA w/guideShot Option?
The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SUPRIA w/guideShot Option?
The FDA product code for SUPRIA w/guideShot Option is JAK.
相关临床试验
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列明Hitachi Medical Systems America, Inc.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：JAK）
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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