Collagentex Rx-1
K号: K162022 · 2016-12-22
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决定日期2016-12-22
产品代码NHN
咨询委员会PM
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决定实质等同
器械摘要
Collagentex Rx-1 is the device name listed in this FDA 510(k) record. The listed applicant is Tanses Technologies, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K162022. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Collagentex Rx-1?
Collagentex Rx-1 is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Tanses Technologies, Inc.. The 510(k) number is K162022.
When did Collagentex Rx-1 receive FDA 510(k) clearance?
Collagentex Rx-1 received FDA 510(k) clearance on 2016-12-22, under 510(k) number K162022.
Who is the listed applicant for Collagentex Rx-1?
The FDA 510(k) record lists Tanses Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Collagentex Rx-1?
The FDA product code for Collagentex Rx-1 is NHN.
相关临床试验
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列明Tanses Technologies, Inc.为申报人的其他记录
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：NHN）
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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