ActiPatch
K号: K192234 · 2020-01-31
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决定日期2020-01-31
产品代码PQY
咨询委员会PM
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决定实质等同
器械摘要
ActiPatch is the device name listed in this FDA 510(k) record. The listed applicant is Bioelectronics Corporation. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K192234. The device is classified under product code PQY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ActiPatch?
ActiPatch is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Bioelectronics Corporation. The 510(k) number is K192234.
When did ActiPatch receive FDA 510(k) clearance?
ActiPatch received FDA 510(k) clearance on 2020-01-31, under 510(k) number K192234.
Who is the listed applicant for ActiPatch?
The FDA 510(k) record lists Bioelectronics Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ActiPatch?
The FDA product code for ActiPatch is PQY.
相关临床试验
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列明Bioelectronics Corporation为申报人的其他记录
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相关器械（代码：PQY）
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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