twion
K号: K151717 · 2016-02-23
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申请人Alber GmbH
决定日期2016-02-23
产品代码ITI
咨询委员会PM
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决定实质等同
器械摘要
twion is the device name listed in this FDA 510(k) record. The listed applicant is Alber GmbH. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K151717. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the twion?
twion is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Alber GmbH. The 510(k) number is K151717.
When did twion receive FDA 510(k) clearance?
twion received FDA 510(k) clearance on 2016-02-23, under 510(k) number K151717.
Who is the listed applicant for twion?
The FDA 510(k) record lists Alber GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for twion?
The FDA product code for twion is ITI.
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Alber GmbH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：ITI）
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。
K262582电动轮椅（GP100）Suzhou Green Pine Medical Co., Ltd.K262054电动轮椅Yongkang Joymax Medical Technology Co., Ltd.K260053电动轮椅（OS-R-M01I）Beijing OrionStar Technology Co., Ltd.K260229电动轮椅（HC819N，HC830N，HC831N）Yongkang Hengyi Vehicle Co., Ltd.K261354电动轮椅（D03）Foshan Sowell Medical Technology Co., Ltd.K261149电动轮椅（DY611A-2，DY612A-1）Zhejiang Lumbre Electric Appliance Co., Ltd.
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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