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510(k) K830163

IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS by Intl. Business Machines — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1983
Date Received
January 18, 1983
Clearance Type
Traditional
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 Intl. Business Machines

  • K831004 — AUTOMATED 8400 BLOOD CELL SEPARATOR (September 12, 1983)
  • K812355 — IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 (September 9, 1981)
  • K810988 — IBM 5885 DIGITAL ECG ACQUISITION CART (May 1, 1981)
  • K810989 — IBM 5880 ACQUISITION & ANALYSIS CART TEL (May 1, 1981)
  • K772353 — EKG ACQUISITION & ANALYSIS CART (January 6, 1978)
  • K771258 — BLOOD CELL SEPARATOR 2997 (September 6, 1977)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (January 10, 1977)

Other clearances for product code DSI

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  • K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (July 29, 2025)
  • 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)