胎儿多普勒U8-25，U9-25
K号: K252669 · 2026-01-08
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决定日期2026-01-08
产品代码KNG
咨询委员会OB
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决定实质等同
器械摘要
Fetal Doppler U8-25, U9-25 is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Xiaolan Town Senlan Electronic Factory. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K252669. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Fetal Doppler U8-25, U9-25?
Fetal Doppler U8-25, U9-25 is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is Zhongshan Xiaolan Town Senlan Electronic Factory. The 510(k) number is K252669.
When did Fetal Doppler U8-25, U9-25 receive FDA 510(k) clearance?
Fetal Doppler U8-25, U9-25 received FDA 510(k) clearance on 2026-01-08, under 510(k) number K252669.
Who is the listed applicant for Fetal Doppler U8-25, U9-25?
The FDA 510(k) record lists Zhongshan Xiaolan Town Senlan Electronic Factory as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fetal Doppler U8-25, U9-25?
The FDA product code for Fetal Doppler U8-25, U9-25 is KNG.
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：KNG）
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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