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FDA 510(k), K170565, LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
FDA 510(k), K170565, LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
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510(K) Number: K170565
Device Name: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Manufacturer: Stefanie Martinez-Koenig
Device Classification Name: Outpatient Cardiac Telemetry
Regulation Number: QYX
Classification Product Code: 02/27/2017
Date Received: 08/01/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Manufacturer: Stefanie Martinez-Koenig
Device Classification Name: Outpatient Cardiac Telemetry
Regulation Number: QYX
Classification Product Code: 02/27/2017
Date Received: 08/01/2017
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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