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510(k) K180472

ViSi Mobile Monitoring System by Sotera Wireless, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2018
Date Received
February 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Sotera Wireless, Inc.

  • K152341 — ViSi Mobile Monitoring System (December 14, 2015)
  • K142827 — Visi Mobile Monitoring System, Visi Mobile Chest Sensor (July 20, 2015)
  • K150361 — ViSi Mobile Monitoring System (April 30, 2015)
  • K143751 — Visi Mobile Monitoring System (January 23, 2015)
  • K133586 — VISI MOBILE MONITIORING SYSTEM (December 18, 2013)
  • K130709 — VISI MOBILE MONITORING SYSTEM (October 7, 2013)
  • K122036 — VISI MOBILE MONITORING SYSTEM (August 15, 2012)
  • K112478 — VISI MOBILE MONITORING SYSTEM (March 22, 2012)

Other clearances for product code MHX

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  • K252589 — Corvair Monza (January 9, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)