WiScope 数字内窥镜系统
K号: K181977 · 2018-08-14
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决定日期2018-08-14
产品代码FGB
咨询委员会GU
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决定实质等同
器械摘要
WiScope Digital Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is OTU Medical, Inc.. It received FDA 510(k) clearance on 2018-08-14 under 510(k) number K181977. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the WiScope Digital Endoscope System?
WiScope Digital Endoscope System is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is OTU Medical, Inc.. The 510(k) number is K181977.
When did WiScope Digital Endoscope System receive FDA 510(k) clearance?
WiScope Digital Endoscope System received FDA 510(k) clearance on 2018-08-14, under 510(k) number K181977.
Who is the listed applicant for WiScope Digital Endoscope System?
The FDA 510(k) record lists OTU Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WiScope Digital Endoscope System?
The FDA product code for WiScope Digital Endoscope System is FGB.
相关临床试验
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列明OTU Medical, 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：FGB）
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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