Human Tecar HCR 1002
K号: K181211 · 2018-09-10
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器械摘要
Human Tecar HCR 1002 is the device name listed in this FDA 510(k) record. The listed applicant is Unibell S.R.L. It received FDA 510(k) clearance on 2018-09-10 under 510(k) number K181211. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Human Tecar HCR 1002?
Human Tecar HCR 1002 is a medical device that received FDA 510(k) clearance on 2018-09-10. The listed applicant is Unibell S.R.L. The 510(k) number is K181211.
When did Human Tecar HCR 1002 receive FDA 510(k) clearance?
Human Tecar HCR 1002 received FDA 510(k) clearance on 2018-09-10, under 510(k) number K181211.
Who is the listed applicant for Human Tecar HCR 1002?
The FDA 510(k) record lists Unibell S.R.L as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Human Tecar HCR 1002?
The FDA product code for Human Tecar HCR 1002 is PBX.
相关临床试验
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相关器械（代码：PBX）
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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