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510(k) K020661

UNITY IS PATIENT VIEWER by General Electric Medical Systems Information Techn — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2002
Date Received
March 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
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)
  • K021366 — MAC-LAB/CARDIOLAB EP/COMBOLAB (July 3, 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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  • K233834 — Infinity Gateway Suite (July 12, 2024)
  • K233418 — Biofourmis Everion+ (G2) (May 9, 2024)
  • K232548 — Corsano CardioWatch 287-2 System (March 22, 2024)
  • K231506 — Current Health System (August 24, 2023)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)