外部上肢震颤刺激器
K号: K182706 · 2018-10-25
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决定日期2018-10-25
产品代码QBC
咨询委员会NE
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决定实质等同
器械摘要
External upper limb tremor stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Cala Health, Inc.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K182706. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the External upper limb tremor stimulator?
External upper limb tremor stimulator is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Cala Health, Inc.. The 510(k) number is K182706.
When did External upper limb tremor stimulator receive FDA 510(k) clearance?
External upper limb tremor stimulator received FDA 510(k) clearance on 2018-10-25, under 510(k) number K182706.
Who is the listed applicant for External upper limb tremor stimulator?
The FDA 510(k) record lists Cala Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for External upper limb tremor stimulator?
The FDA product code for External upper limb tremor stimulator is QBC.
相关临床试验
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列明Cala Health, 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：QBC）
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。
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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