无菌和非无菌超声凝胶
K号: K232957 · 2023-12-15
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器械摘要
Sterile and Non-Sterile Ultrasound Gels is the device name listed in this FDA 510(k) record. The listed applicant is Jianerkang Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232957. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sterile and Non-Sterile Ultrasound Gels?
Sterile and Non-Sterile Ultrasound Gels is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Jianerkang Medical Co., Ltd.. The 510(k) number is K232957.
When did Sterile and Non-Sterile Ultrasound Gels receive FDA 510(k) clearance?
Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232957.
Who is the listed applicant for Sterile and Non-Sterile Ultrasound Gels?
The FDA 510(k) record lists Jianerkang Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile and Non-Sterile Ultrasound Gels?
The FDA product code for Sterile and Non-Sterile Ultrasound Gels is MUI.
相关临床试验
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相关器械（代码：MUI）
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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