口袋式阴道镜系统
K号: K181034 · 2018-09-21
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决定日期2018-09-21
产品代码HEX
咨询委员会OB
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决定实质等同
器械摘要
Pocket Colposcope System is the device name listed in this FDA 510(k) record. The listed applicant is Hadleigh Health Technologies, LLC. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K181034. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pocket Colposcope System?
Pocket Colposcope System is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Hadleigh Health Technologies, LLC. The 510(k) number is K181034.
When did Pocket Colposcope System receive FDA 510(k) clearance?
Pocket Colposcope System received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181034.
Who is the listed applicant for Pocket Colposcope System?
The FDA 510(k) record lists Hadleigh Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pocket Colposcope System?
The FDA product code for Pocket Colposcope System is HEX.
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：HEX）
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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