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FDA 510(k), K193473, LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
FDA 510(k), K193473, LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
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510(K) Number: K193473
Device Name: LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
Manufacturer: Boston Scientific Corporation
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 12/16/2019
Decision Date: 06/26/2020
Regulation Medical Specialty: Cardiovascular
Device Name: LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
Manufacturer: Boston Scientific Corporation
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 12/16/2019
Decision Date: 06/26/2020
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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