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FDA 510(k)

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

K-Number: K193310 · 2020-03-17

ApplicantAbbott (St. Jude Medical)
Decision Date2020-03-17
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

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Other records listing Abbott (St. Jude Medical) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230286Assert-IQ™ Insertable Cardiac MonitorABBOTT MEDICALK212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K192593Confirm Rx Insertable Cardiac MonitorAbbottK190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)

Official Source

View on FDA Database →

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

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