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510(k) K173107

Vios Central Station Monitor Software, Vios Central Server Software by Vios Medical, Inc. — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2018
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

Other clearances by Vios Medical, Inc.

  • K172586 — Vios Monitoring System™ Model 2050 (June 22, 2018)
  • K150992 — Vios Monitoring System (December 16, 2015)

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  • K170460 — Sorin Connect (June 8, 2017)
  • K170537 — Nexxis OR, Nexxis (April 21, 2017)
  • K161880 — NIVR58-T kit (March 14, 2017)
  • K161767 — Philips IntelliVue GuardianSoftware (January 27, 2017)