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FDA 510(k), K181918, CardioInsight Cardiac Mapping System
FDA 510(k), K181918, CardioInsight Cardiac Mapping System
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$149.00 USD
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510(K) Number: K181918
Device Name: CardioInsight Cardiac Mapping System
Manufacturer: Janell Colley
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: 07/18/2018
Date Received: 11/08/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CardioInsight Cardiac Mapping System
Manufacturer: Janell Colley
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: 07/18/2018
Date Received: 11/08/2018
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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