剪切应力治疗SST 3000
K号: K182163 · 2019-07-09
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决定日期2019-07-09
产品代码IPF
咨询委员会PM
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决定实质等同
器械摘要
Shear Stress Therapeutics SST 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Shear Stress Therapeutics, LLC. It received FDA 510(k) clearance on 2019-07-09 under 510(k) number K182163. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Shear Stress Therapeutics SST 3000?
Shear Stress Therapeutics SST 3000 is a medical device that received FDA 510(k) clearance on 2019-07-09. The listed applicant is Shear Stress Therapeutics, LLC. The 510(k) number is K182163.
When did Shear Stress Therapeutics SST 3000 receive FDA 510(k) clearance?
Shear Stress Therapeutics SST 3000 received FDA 510(k) clearance on 2019-07-09, under 510(k) number K182163.
Who is the listed applicant for Shear Stress Therapeutics SST 3000?
The FDA 510(k) record lists Shear Stress Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Shear Stress Therapeutics SST 3000?
The FDA product code for Shear Stress Therapeutics SST 3000 is IPF.
相关临床试验
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相关器械（代码：IPF）
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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