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FDA 510(k), K132649, REVEAL LINQ INSERTABLE CARDIAC MONITOR
FDA 510(k), K132649, REVEAL LINQ INSERTABLE CARDIAC MONITOR
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510(K) Number: K132649
Device Name: REVEAL LINQ INSERTABLE CARDIAC MONITOR
Manufacturer: ERIC KALMES
Device Classification Name: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Regulation Number: MXD
Classification Product Code: 08/26/2013
Date Received: 02/14/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: REVEAL LINQ INSERTABLE CARDIAC MONITOR
Manufacturer: ERIC KALMES
Device Classification Name: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Regulation Number: MXD
Classification Product Code: 08/26/2013
Date Received: 02/14/2014
Decision Date: Substantially Equivalent (SESE)
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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