胎儿多普勒，型号FD88
K号: K182710 · 2019-03-01
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决定日期2019-03-01
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, Model FD88 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzzhen Luckcome Technology Inc., Ltd.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K182710. 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, Model FD88?
Fetal Doppler, Model FD88 is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Shenzzhen Luckcome Technology Inc., Ltd.. The 510(k) number is K182710.
When did Fetal Doppler, Model FD88 receive FDA 510(k) clearance?
Fetal Doppler, Model FD88 received FDA 510(k) clearance on 2019-03-01, under 510(k) number K182710.
Who is the listed applicant for Fetal Doppler, Model FD88?
The FDA 510(k) record lists Shenzzhen Luckcome Technology Inc., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fetal Doppler, Model FD88?
The FDA product code for Fetal Doppler, Model FD88 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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