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FDA 510(k), K172396, EnSite Velocity Cardiac Mapping System v5.2
FDA 510(k), K172396, EnSite Velocity Cardiac Mapping System v5.2
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510(K) Number: K172396
Device Name: EnSite Velocity Cardiac Mapping System v5.2
Manufacturer: Melissa Frank
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: KXA
Date Received: 08/08/2017
Decision Date: 04/23/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: EnSite Velocity Cardiac Mapping System v5.2
Manufacturer: Melissa Frank
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: KXA
Date Received: 08/08/2017
Decision Date: 04/23/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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