FDA 510(k)

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

K-Number: K193310 · 2020-03-17

Decision Date2020-03-17

Product CodeMXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Abbott (St. Jude Medical). The 510(k) number is K193310.

When was myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) approved by the FDA?

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

What company makes myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is manufactured by Abbott (St. Jude Medical).

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.

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Related Devices (Code: MXC)

K173232myMerlin(TM) Mobile Application Model APP1001St Jude Medical K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. K192593Confirm Rx Insertable Cardiac MonitorAbbott K190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) K182981Confirm Rx Insertable Cardiac MonitorAbbott K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.