ProMedTek Model C1400短波透热治疗仪
K号: K162240 · 2016-11-17
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决定日期2016-11-17
产品代码IMJ
咨询委员会PM
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决定实质等同
器械摘要
ProMedTek Model C1400 Shortwave Diathermy Device is the device name listed in this FDA 510(k) record. The listed applicant is Promedtek, Inc.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162240. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ProMedTek Model C1400 Shortwave Diathermy Device?
ProMedTek Model C1400 Shortwave Diathermy Device is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Promedtek, Inc.. The 510(k) number is K162240.
When did ProMedTek Model C1400 Shortwave Diathermy Device receive FDA 510(k) clearance?
ProMedTek Model C1400 Shortwave Diathermy Device received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162240.
Who is the listed applicant for ProMedTek Model C1400 Shortwave Diathermy Device?
The FDA 510(k) record lists Promedtek, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device?
The FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device is IMJ.
相关临床试验
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相关器械（代码：IMJ）
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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