FDA 510(k)

SMART M-CELL PRP 浓缩系统

K号: K250516 · 2026-04-02

决定日期2026-04-02

产品代码QBV

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

SMART M-CELL PRP Concentration System is the device name listed in this FDA 510(k) record. The listed applicant is Miracell Co., Ltd.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K250516. The device is classified under product code QBV. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SMART M-CELL PRP Concentration System?

SMART M-CELL PRP Concentration System is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Miracell Co., Ltd.. The 510(k) number is K250516.

When did SMART M-CELL PRP Concentration System receive FDA 510(k) clearance?

SMART M-CELL PRP Concentration System received FDA 510(k) clearance on 2026-04-02, under 510(k) number K250516.

Who is the listed applicant for SMART M-CELL PRP Concentration System?

The FDA 510(k) record lists Miracell Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART M-CELL PRP Concentration System?

The FDA product code for SMART M-CELL PRP Concentration System is QBV.

列明Miracell Co., Ltd.为申报人的其他记录

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。

K250518SMART M-CELL 骨髓浓缩系统

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。