Paragon 2
K号: K162687 · 2016-10-21
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器械摘要
Paragon 2 is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Medical Systems, LLC. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K162687. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Paragon 2?
Paragon 2 is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Meridian Medical Systems, LLC. The 510(k) number is K162687.
When did Paragon 2 receive FDA 510(k) clearance?
Paragon 2 received FDA 510(k) clearance on 2016-10-21, under 510(k) number K162687.
Who is the listed applicant for Paragon 2?
The FDA 510(k) record lists Meridian Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Paragon 2?
The FDA product code for Paragon 2 is IZL.
相关临床试验
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。
相关器械（代码：IZL）
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。
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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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