ANT-X 系统
K号: K230185 · 2023-06-01
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器械摘要
ANT-X System is the device name listed in this FDA 510(k) record. The listed applicant is Ndr Medical Technology Pte. , Ltd.. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K230185. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ANT-X System?
ANT-X System is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Ndr Medical Technology Pte. , Ltd.. The 510(k) number is K230185.
When did ANT-X System receive FDA 510(k) clearance?
ANT-X System received FDA 510(k) clearance on 2023-06-01, under 510(k) number K230185.
Who is the listed applicant for ANT-X System?
The FDA 510(k) record lists Ndr Medical Technology Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ANT-X System?
The FDA product code for ANT-X System is OWB.
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：OWB）
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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