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510(k) K023100

ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS by General Electric Medical Systems Information Techn — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
September 18, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • 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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