Home / 510(k) Clearances / K030419

510(k) K030419

VITERION 100 TELEHEALTH MONITOR by Viterion Telehealthcare, LLC — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2003
Date Received
February 10, 2003
Clearance Type
Traditional
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 for product code MWI

  • K250135 — WAVE Clinical Platform (2.0.000) (January 16, 2026)
  • 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)