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510(k) K142356

Connex Spot Monitor,901058 Vital Signs Monitor Core by Welch Allyn, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
August 25, 2014
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)
  • K212473 — Welch Allyn Connex Central Station (October 28, 2022)
  • 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)
  • 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

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  • 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)