Bloomlife MFM-Pro
K号: K222327 · 2023-02-13
广告
决定日期2023-02-13
产品代码HGM
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
Bloomlife MFM-Pro is the device name listed in this FDA 510(k) record. The listed applicant is Bloom Technologies NV. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K222327. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bloomlife MFM-Pro?
Bloomlife MFM-Pro is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Bloom Technologies NV. The 510(k) number is K222327.
When did Bloomlife MFM-Pro receive FDA 510(k) clearance?
Bloomlife MFM-Pro received FDA 510(k) clearance on 2023-02-13, under 510(k) number K222327.
Who is the listed applicant for Bloomlife MFM-Pro?
The FDA 510(k) record lists Bloom Technologies NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bloomlife MFM-Pro?
The FDA product code for Bloomlife MFM-Pro is HGM.
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：HGM）
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