FDA 510(k)

Citrated: K, KH, RTH, FFH

K号: K232018 · 2024-03-29

决定日期2024-03-29

产品代码JPA

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Citrated: K, KH, RTH, FFH is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2024-03-29 under 510(k) number K232018. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Citrated: K, KH, RTH, FFH?

Citrated: K, KH, RTH, FFH is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Haemonetics Corporation. The 510(k) number is K232018.

When did Citrated: K, KH, RTH, FFH receive FDA 510(k) clearance?

Citrated: K, KH, RTH, FFH received FDA 510(k) clearance on 2024-03-29, under 510(k) number K232018.

Who is the listed applicant for Citrated: K, KH, RTH, FFH?

The FDA 510(k) record lists Haemonetics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Citrated: K, KH, RTH, FFH?

The FDA product code for Citrated: K, KH, RTH, FFH is JPA.

列明Haemonetics Corporation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。

K243858TEG 6s 止血系统柠檬酸盐：K, KH, RT, FF 测定卡 K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)K183160TEG 6s 止血系统，TEG 6s 柠檬酸盐：K, RT, FF 测定卡 K160502TEG 6s 止血系统 K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System K160197Haemonetics Cell Saver Elite Autotransfusion System

查看所有 7 个设备 →

官方来源

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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。