Megapulse III 短波透热疗法设备
K号: K153456 · 2016-06-14
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决定日期2016-06-14
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
Megapulse III Shortwave Diathermy is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Care Plus. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K153456. 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 Megapulse III Shortwave Diathermy?
Megapulse III Shortwave Diathermy is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is Accelerated Care Plus. The 510(k) number is K153456.
When did Megapulse III Shortwave Diathermy receive FDA 510(k) clearance?
Megapulse III Shortwave Diathermy received FDA 510(k) clearance on 2016-06-14, under 510(k) number K153456.
Who is the listed applicant for Megapulse III Shortwave Diathermy?
The FDA 510(k) record lists Accelerated Care Plus as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Megapulse III Shortwave Diathermy?
The FDA product code for Megapulse III Shortwave Diathermy 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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