FDA 510(k)

MasterScope，MasterScope CT，MasterScope ECG，MasterScope WSSU

K号: K202754 · 2021-01-28

决定日期2021-01-28

产品代码BTY

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is the device name listed in this FDA 510(k) record. The listed applicant is Eresearchtechnology GmbH. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K202754. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Eresearchtechnology GmbH. The 510(k) number is K202754.

When did MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU receive FDA 510(k) clearance?

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU received FDA 510(k) clearance on 2021-01-28, under 510(k) number K202754.

Who is the listed applicant for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

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

What is the FDA product code for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

The FDA product code for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is BTY.

列明Eresearchtechnology GmbH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。

K223629SpiroSphere, SpiroSphereECG, CardioSphere K173937SpiroSphere

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。