FDA 510(k)

我的梅林移动应用（Android），我的梅林移动应用（iOS）

K号: K193310 · 2020-03-17

决定日期2020-03-17

产品代码MXC

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

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K193310. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is Abbott (St. Jude Medical). The 510(k) number is K193310.

When did myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) receive FDA 510(k) clearance?

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) received FDA 510(k) clearance on 2020-03-17, under 510(k) number K193310.

Who is the listed applicant for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

The FDA 510(k) record lists Abbott (St. Jude Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

The FDA product code for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is MXC.

列明Abbott (St. Jude Medical)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。

K212206Jot Dx 可植入式心脏监测器 K202876Confirm Rx 可植入式心脏监测器 K202888Confirm Rx 可植入式心脏监测器 K200721Agilis HisPro 可弯曲电极导管 K190295Confirm Rx 可植入式心脏监测器

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。