免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

CSMC心脏套件

K号: K172609 · 2017-11-03

决定日期2017-11-03
产品代码KPS
咨询委员会RA
决定实质等同

器械摘要

CSMC Cardiac Suite is the device name listed in this FDA 510(k) record. The listed applicant is Cedars-Sinai Medical Center. It received FDA 510(k) clearance on 2017-11-03 under 510(k) number K172609. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CSMC Cardiac Suite?

CSMC Cardiac Suite is a medical device that received FDA 510(k) clearance on 2017-11-03. The listed applicant is Cedars-Sinai Medical Center. The 510(k) number is K172609.

When did CSMC Cardiac Suite receive FDA 510(k) clearance?

CSMC Cardiac Suite received FDA 510(k) clearance on 2017-11-03, under 510(k) number K172609.

Who is the listed applicant for CSMC Cardiac Suite?

The FDA 510(k) record lists Cedars-Sinai Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSMC Cardiac Suite?

The FDA product code for CSMC Cardiac Suite is KPS.

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。

相关器械(代码:KPS)

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。

↑