假体，乳房，可充气，内部，盐水填充
PMA编号：P120011 · 2025-02-11
广告
决定日期2025-02-11
PMA 编号P120011
产品代码FWM
设备分类第3类
医疗专科G
法规编号21 CFR 8
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
器械摘要
Prosthesis, breast, inflatable, internal, saline is the device name listed in this FDA 510(k) record. The listed applicant is Bimini Health Tech. It received FDA 510(k) clearance on 2025-02-11. The device is classified under product code FWM. It was reviewed by the SU advisory panel.
常见问题
What is the Prosthesis, breast, inflatable, internal, saline?
Prosthesis, breast, inflatable, internal, saline is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Bimini Health Tech.
When did Prosthesis, breast, inflatable, internal, saline receive FDA 510(k) clearance?
The clearance date for Prosthesis, breast, inflatable, internal, saline can be found in the official FDA records.
Who is the listed applicant for Prosthesis, breast, inflatable, internal, saline?
The FDA 510(k) record lists Bimini Health Tech as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Prosthesis, breast, inflatable, internal, saline?
The FDA product code for Prosthesis, breast, inflatable, internal, saline is FWM.
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。
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