Home / 510(k) Clearances / K191989

510(k) K191989

WVSM (Wireless Vital Signs Monitor) RWC + miniCap by Athena Gtx — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2020
Date Received
July 25, 2019
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 by Athena Gtx

  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)
  • K173203 — Athena GTX Device Management Suite (ADMS) Software (March 14, 2018)
  • K160582 — WiCap (September 2, 2016)
  • K153459 — TACVAC (January 28, 2016)
  • K130957 — WVSM (WIRLESS VITAL SIGNS MONITOR) (April 30, 2013)
  • K113165 — MINI-MEDIC (February 2, 2012)
  • K101674 — WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 (July 21, 2010)

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)