FDA 510(k)

FloPump 32mL，无菌，FloPump 32mL，非无菌

K号: K170029 · 2017-12-15

决定日期2017-12-15

产品代码KFM

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corporation. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K170029. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile?

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is International Biophysics Corporation. The 510(k) number is K170029.

When did FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile receive FDA 510(k) clearance?

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile received FDA 510(k) clearance on 2017-12-15, under 510(k) number K170029.

Who is the listed applicant for FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile?

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

What is the FDA product code for FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile?

The FDA product code for FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is KFM.

列明International Biophysics 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。

K193663FloPump 57mL 离心泵

相关器械（代码：KFM）

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。

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官方来源

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