P200TxE
K号: K190732 · 2019-07-31
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申请人Optos Plc.
决定日期2019-07-31
产品代码OBO
咨询委员会OP
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决定实质等同
器械摘要
P200TxE is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K190732. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the P200TxE?
P200TxE is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Optos Plc.. The 510(k) number is K190732.
When did P200TxE receive FDA 510(k) clearance?
P200TxE received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190732.
Who is the listed applicant for P200TxE?
The FDA 510(k) record lists Optos Plc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for P200TxE?
The FDA product code for P200TxE is OBO.
列明Optos Plc.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：OBO）
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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