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510(k) K020290

DASH 3000/4000 PATIENT MONITOR by General Electric Medical Systems Information Techn — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2002
Date Received
January 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by General Electric Medical Systems Information Techn

  • K023380 — T-WAVE ALTERMANS (TWA) ALGORITHM OPTION (December 3, 2002)
  • K021470 — SEER LIGHT COMPACT DIGITAL HOLTER RECORDER (November 14, 2002)
  • K023100 — ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS (October 11, 2002)
  • K021454 — UNITY NETWORK ID (October 1, 2002)
  • K021366 — MAC-LAB/CARDIOLAB EP/COMBOLAB (July 3, 2002)
  • K020661 — UNITY IS PATIENT VIEWER (May 24, 2002)
  • K021325 — MODIFICATION OF APEXPRO TELEMETRY SYSTEM (May 7, 2002)
  • K020524 — PATIENTNET MONITORING SYSTEM (March 20, 2002)
  • K012467 — SOLAR 8000M SYSTEM (February 11, 2002)
  • K014108 — MAC 5000 ECG ANALYSIS SYSTEM (January 10, 2002)

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