RectalPro 75 Endorectal Balloon
K号: K180478 · 2018-11-13
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器械摘要
RectalPro 75 Endorectal Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Qlrad International , Ltd.. It received FDA 510(k) clearance on 2018-11-13 under 510(k) number K180478. The device is classified under product code PCT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RectalPro 75 Endorectal Balloon?
RectalPro 75 Endorectal Balloon is a medical device that received FDA 510(k) clearance on 2018-11-13. The listed applicant is Qlrad International , Ltd.. The 510(k) number is K180478.
When did RectalPro 75 Endorectal Balloon receive FDA 510(k) clearance?
RectalPro 75 Endorectal Balloon received FDA 510(k) clearance on 2018-11-13, under 510(k) number K180478.
Who is the listed applicant for RectalPro 75 Endorectal Balloon?
The FDA 510(k) record lists Qlrad International , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RectalPro 75 Endorectal Balloon?
The FDA product code for RectalPro 75 Endorectal Balloon is PCT.
相关临床试验
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相关器械（代码：PCT）
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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