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510(k) K021366

MAC-LAB/CARDIOLAB EP/COMBOLAB by General Electric Medical Systems Information Techn — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2002
Date Received
April 30, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
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)
  • K020290 — DASH 3000/4000 PATIENT MONITOR (August 14, 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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  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
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