System 83 Plus 洗涤/消毒器
K号: K173590 · 2020-03-30
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决定日期2020-03-30
产品代码FEB
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
System 83 Plus Washer/Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is Custom Ultrasonics, Inc.. It received FDA 510(k) clearance on 2020-03-30 under 510(k) number K173590. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the System 83 Plus Washer/Disinfector?
System 83 Plus Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2020-03-30. The listed applicant is Custom Ultrasonics, Inc.. The 510(k) number is K173590.
When did System 83 Plus Washer/Disinfector receive FDA 510(k) clearance?
System 83 Plus Washer/Disinfector received FDA 510(k) clearance on 2020-03-30, under 510(k) number K173590.
Who is the listed applicant for System 83 Plus Washer/Disinfector?
The FDA 510(k) record lists Custom Ultrasonics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for System 83 Plus Washer/Disinfector?
The FDA product code for System 83 Plus Washer/Disinfector is FEB.
相关临床试验
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。
列明Custom Ultrasonics, 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：FEB）
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。
K241168System 83 Revolve 内窥镜洗涤/消毒器Wassenburg Medical, Inc.K243433启辉3000清洗和液体化学灭菌剂处理系统STERIS CorporationK230930启辉3000清洗和液体化学灭菌处理系统STERIS CorporationK213833SCOPE BUDDY PLUS 内窥镜冲洗辅助工具Medivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.
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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