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510(k) K150361

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2015
Date Received
February 12, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Sotera Wireless, Inc.

  • K180472 — ViSi Mobile Monitoring System (June 19, 2018)
  • K152341 — ViSi Mobile Monitoring System (December 14, 2015)
  • K142827 — Visi Mobile Monitoring System, Visi Mobile Chest Sensor (July 20, 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 MWI

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  • K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (August 27, 2025)
  • K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (June 6, 2025)
  • K241958 — WARD-CSS (v1.2.x) (February 14, 2025)
  • K243146 — iCare APP (February 3, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (December 10, 2024)
  • K233446 — AMC Health CareConsole (September 27, 2024)
  • K240236 — Happy Ring Health Monitoring System (September 24, 2024)
  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)