Iovera系统
K号: K211334 · 2021-09-10
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决定日期2021-09-10
产品代码GXH
咨询委员会NE
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器械摘要
Iovera System is the device name listed in this FDA 510(k) record. The listed applicant is Pacira Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K211334. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Iovera System?
Iovera System is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Pacira Pharmaceuticals, Inc.. The 510(k) number is K211334.
When did Iovera System receive FDA 510(k) clearance?
Iovera System received FDA 510(k) clearance on 2021-09-10, under 510(k) number K211334.
Who is the listed applicant for Iovera System?
The FDA 510(k) record lists Pacira Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Iovera System?
The FDA product code for Iovera System is GXH.
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。
相关器械（代码：GXH）
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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