Home / 510(k) Clearances / K896771

510(k) K896771

EKG, ECG KENZ, ECG 302 by Cambridge Medical Instruments, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
December 1, 1989
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 Cambridge Medical Instruments, Inc.

  • K896772 — EKG, ECG KENZ, ECG 303 (February 26, 1990)
  • K895961 — MODEL MC6500 ELECTROCARDIOGRAPH (January 4, 1990)
  • K883454 — MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH (January 25, 1989)
  • K871993 — MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH (November 23, 1987)
  • K862748 — MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION (August 25, 1986)
  • K854282 — PREVIEW XT (January 8, 1986)
  • K854283 — CAMBRIDGE MODEL XT1000 (November 13, 1985)

Other clearances for product code DSI

  • K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0) (January 23, 2026)
  • 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)