EPAD 2系统
K号: K182542 · 2019-02-22
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决定日期2019-02-22
产品代码GWF
咨询委员会NE
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器械摘要
The EPAD 2 System is the device name listed in this FDA 510(k) record. The listed applicant is Safeop Surgical, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K182542. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the The EPAD 2 System?
The EPAD 2 System is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Safeop Surgical, Inc.. The 510(k) number is K182542.
When did The EPAD 2 System receive FDA 510(k) clearance?
The EPAD 2 System received FDA 510(k) clearance on 2019-02-22, under 510(k) number K182542.
Who is the listed applicant for The EPAD 2 System?
The FDA 510(k) record lists Safeop Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The EPAD 2 System?
The FDA product code for The EPAD 2 System is GWF.
相关临床试验
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相关器械（代码：GWF）
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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