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510(k) K173107

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

K173107 is an FDA 510(k) premarket notification submitted by Vios Medical, Inc. for the device "Vios Central Station Monitor Software, Vios Central Server Software". The FDA issued a decision of Substantially Equivalent on July 26, 2018. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Vios Medical, Inc. has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code DXJ

  • K212003 — ESSENZ Patient Monitor (November 10, 2021)
  • K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X) (September 30, 2021)
  • K201162 — Essence 55SP Large Monitor System (August 27, 2020)
  • K180534 — Philips IntelliVue GuardianSoftware (July 16, 2018)
  • K173381 — Nexxis OR (February 22, 2018)
  • K172969 — Essence 55S Large Monitor System (January 26, 2018)
  • 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)

FDA data resources