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510(k) K033378

VITAL SIGNS MONITOR, PROPAQ LT by Welch Allyn Protocol, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2004
Date Received
October 22, 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 by Welch Allyn Protocol, Inc.

  • K070204 — LINK TO ACUITY CLINICIAN NOTIFIER (March 23, 2007)
  • K063419 — MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) (December 4, 2006)
  • K031740 — VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES (August 26, 2003)
  • K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM (August 21, 2002)
  • K021681 — MICROPAQ, MODELS 402, 404 (July 23, 2002)
  • K012451 — PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 (August 20, 2001)

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)