MyMerlin Mobile Application (Android), MyMerlin Mobile Application (iOS)

Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

Abbott (St. Jude Medical)

The following data is part of a premarket notification filed by Abbott (st. Jude Medical) with the FDA for Mymerlin Mobile Application (android), Mymerlin Mobile Application (ios).

Pre-market Notification Details

Device IDK193310
510k NumberK193310
Device Name:MyMerlin Mobile Application (Android), MyMerlin Mobile Application (iOS)
ClassificationRecorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Applicant Abbott (St. Jude Medical) 15900 Valley View Court Sylmar,  CA  91342
ContactVanessa Powell
CorrespondentVanessa Powell
Abbott (St. Jude Medical) 15900 Valley View Court Sylmar,  CA  91342
Product CodeMXC  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-29
Decision Date2020-03-17

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