EZ-Cover
K号: K191491 · 2020-06-05
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器械摘要
EZ-Cover is the device name listed in this FDA 510(k) record. The listed applicant is Medxpress.Pro. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K191491. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EZ-Cover?
EZ-Cover is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Medxpress.Pro. The 510(k) number is K191491.
When did EZ-Cover receive FDA 510(k) clearance?
EZ-Cover received FDA 510(k) clearance on 2020-06-05, under 510(k) number K191491.
Who is the listed applicant for EZ-Cover?
The FDA 510(k) record lists Medxpress.Pro as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EZ-Cover?
The FDA product code for EZ-Cover is ITX.
相关临床试验
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相关器械（代码：ITX）
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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