Ultimax-i，DREX-UI80 V1.60
K号: K170832 · 2017-07-21
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器械摘要
Ultimax-i, DREX-UI80 V1.60 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K170832. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ultimax-i, DREX-UI80 V1.60?
Ultimax-i, DREX-UI80 V1.60 is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170832.
When did Ultimax-i, DREX-UI80 V1.60 receive FDA 510(k) clearance?
Ultimax-i, DREX-UI80 V1.60 received FDA 510(k) clearance on 2017-07-21, under 510(k) number K170832.
Who is the listed applicant for Ultimax-i, DREX-UI80 V1.60?
The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ultimax-i, DREX-UI80 V1.60?
The FDA product code for Ultimax-i, DREX-UI80 V1.60 is OWB.
相关临床试验
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列明Toshibamedical Systems Corporation为申报人的其他记录
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相关器械（代码：OWB）
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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