Signal 导管
K号: K182635 · 2019-01-10
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决定日期2019-01-10
产品代码EZL
咨询委员会GU
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决定实质等同
器械摘要
Signal Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Safe Medical Design. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K182635. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Signal Catheter?
Signal Catheter is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Safe Medical Design. The 510(k) number is K182635.
When did Signal Catheter receive FDA 510(k) clearance?
Signal Catheter received FDA 510(k) clearance on 2019-01-10, under 510(k) number K182635.
Who is the listed applicant for Signal Catheter?
The FDA 510(k) record lists Safe Medical Design as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Signal Catheter?
The FDA product code for Signal Catheter is EZL.
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：EZL）
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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