FDA 510(k), K172259, PulsioFlex Monitoring System

FDA 510(k), K172259, PulsioFlex Monitoring System

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510(K) Number: K172259
Device Name: PulsioFlex Monitoring System
Manufacturer: Marc Bergenthal
Device Classification Name: Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation Number: DXG
Classification Product Code: KXA
Date Received: 07/27/2017
Decision Date: 01/18/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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