IRIS-XP
K号: K212412 · 2021-09-13
广告
决定日期2021-09-13
产品代码LHQ
咨询委员会OB
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
IRIS-XP is the device name listed in this FDA 510(k) record. The listed applicant is Medicore Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K212412. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IRIS-XP?
IRIS-XP is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Medicore Co., Ltd.. The 510(k) number is K212412.
When did IRIS-XP receive FDA 510(k) clearance?
IRIS-XP received FDA 510(k) clearance on 2021-09-13, under 510(k) number K212412.
Who is the listed applicant for IRIS-XP?
The FDA 510(k) record lists Medicore Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IRIS-XP?
The FDA product code for IRIS-XP is LHQ.
相关器械（代码：LHQ）
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