exCellerator 颈部采集装置
K号: K182049 · 2019-04-25
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决定日期2019-04-25
产品代码HHT
咨询委员会OB
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决定实质等同
器械摘要
exCellerator Cervical Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Excell Company, LLC. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K182049. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the exCellerator Cervical Collection Device?
exCellerator Cervical Collection Device is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Excell Company, LLC. The 510(k) number is K182049.
When did exCellerator Cervical Collection Device receive FDA 510(k) clearance?
exCellerator Cervical Collection Device received FDA 510(k) clearance on 2019-04-25, under 510(k) number K182049.
Who is the listed applicant for exCellerator Cervical Collection Device?
The FDA 510(k) record lists Excell Company, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for exCellerator Cervical Collection Device?
The FDA product code for exCellerator Cervical Collection Device is HHT.
相关临床试验
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相关器械（代码：HHT）
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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