DARI 健康公司
K号: K180880 · 2019-03-07
广告
决定日期2019-03-07
产品代码LXJ
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
DARI Health is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Analytics, Inc.. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K180880. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DARI Health?
DARI Health is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Scientific Analytics, Inc.. The 510(k) number is K180880.
When did DARI Health receive FDA 510(k) clearance?
DARI Health received FDA 510(k) clearance on 2019-03-07, under 510(k) number K180880.
Who is the listed applicant for DARI Health?
The FDA 510(k) record lists Scientific Analytics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DARI Health?
The FDA product code for DARI Health is LXJ.
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：LXJ）
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。
广告