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510(k) K212473

Welch Allyn Connex Central Station by Welch Allyn, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2022
Date Received
August 6, 2021
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 Welch Allyn, Inc.

  • K243598 — Welch Allyn Connex® 360 (Multiple) (July 13, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K223381 — iExaminer System with Panoptic Plus (March 15, 2023)
  • K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (September 10, 2019)
  • K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (July 16, 2018)
  • K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall Syste (June 30, 2017)
  • K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core (December 19, 2014)
  • K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (July 11, 2014)
  • K132807 — MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) (January 31, 2014)
  • K132808 — VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR (November 20, 2013)

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)