Comfort Cover
K号: K161920 · 2016-07-15
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器械摘要
Comfort Cover is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dynamics Corporation. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161920. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Comfort Cover?
Comfort Cover is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Precision Dynamics Corporation. The 510(k) number is K161920.
When did Comfort Cover receive FDA 510(k) clearance?
Comfort Cover received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161920.
Who is the listed applicant for Comfort Cover?
The FDA 510(k) record lists Precision Dynamics Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Comfort Cover?
The FDA product code for Comfort Cover is IZH.
相关临床试验
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相关器械（代码：IZH）
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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