FDA 510(k)

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System

K号: K162423 · 2017-01-03

决定日期2017-01-03

产品代码CAC

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决定实质等同

器械摘要

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2017-01-03 under 510(k) number K162423. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System is a medical device that received FDA 510(k) clearance on 2017-01-03. The listed applicant is Haemonetics Corporation. The 510(k) number is K162423.

When did Haemonetics Cell Saver Elite/Elite+ Autotransfusion System receive FDA 510(k) clearance?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System received FDA 510(k) clearance on 2017-01-03, under 510(k) number K162423.

Who is the listed applicant for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System?

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 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System?

The FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System is CAC.

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 K232018Citrated: K, KH, RTH, FFH 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 K160197Haemonetics Cell Saver Elite Autotransfusion System

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