e-fix E35/E36
K号: K161241 · 2016-10-05
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申请人Alber GmbH
决定日期2016-10-05
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
e-fix E35/E36 is the device name listed in this FDA 510(k) record. The listed applicant is Alber GmbH. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K161241. 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 e-fix E35/E36?
e-fix E35/E36 is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Alber GmbH. The 510(k) number is K161241.
When did e-fix E35/E36 receive FDA 510(k) clearance?
e-fix E35/E36 received FDA 510(k) clearance on 2016-10-05, under 510(k) number K161241.
Who is the listed applicant for e-fix E35/E36?
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 e-fix E35/E36?
The FDA product code for e-fix E35/E36 is ITI.
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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