SMOOV O10
K号: K192016 · 2020-05-19
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申请人Alber GmbH
决定日期2020-05-19
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
SMOOV O10 is the device name listed in this FDA 510(k) record. The listed applicant is Alber GmbH. It received FDA 510(k) clearance on 2020-05-19 under 510(k) number K192016. 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 SMOOV O10?
SMOOV O10 is a medical device that received FDA 510(k) clearance on 2020-05-19. The listed applicant is Alber GmbH. The 510(k) number is K192016.
When did SMOOV O10 receive FDA 510(k) clearance?
SMOOV O10 received FDA 510(k) clearance on 2020-05-19, under 510(k) number K192016.
Who is the listed applicant for SMOOV O10?
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 SMOOV O10?
The FDA product code for SMOOV O10 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。
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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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