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510(k) K022453

MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM by Welch Allyn Protocol, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2002
Date Received
July 26, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
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)
  • K033378 — VITAL SIGNS MONITOR, PROPAQ LT (March 1, 2004)
  • K031740 — VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES (August 26, 2003)
  • K021681 — MICROPAQ, MODELS 402, 404 (July 23, 2002)
  • K012451 — PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 (August 20, 2001)

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  • K240177 — Zio AT® device (A100A1001) (October 30, 2024)
  • K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (October 6, 2023)
  • K231276 — SmartCardia 7L Platform (August 30, 2023)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
  • K182532 — Liba3 System (May 15, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)