Safergel 无菌超声凝胶
K号: K190591 · 2019-10-04
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器械摘要
Safergel Sterile Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Safersonic Us, Inc.. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190591. 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 Safergel Sterile Ultrasound Gel?
Safergel Sterile Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Safersonic Us, Inc.. The 510(k) number is K190591.
When did Safergel Sterile Ultrasound Gel receive FDA 510(k) clearance?
Safergel Sterile Ultrasound Gel received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190591.
Who is the listed applicant for Safergel Sterile Ultrasound Gel?
The FDA 510(k) record lists Safersonic Us, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Safergel Sterile Ultrasound Gel?
The FDA product code for Safergel Sterile Ultrasound Gel 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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