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510(k) K063419

MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) by Welch Allyn Protocol, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2006
Date Received
November 13, 2006
Clearance Type
Special
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)
  • K033378 — VITAL SIGNS MONITOR, PROPAQ LT (March 1, 2004)
  • 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

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  • 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)