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510(k) K002957

SOLAR SPO2 MODULE WITH MASIMO SET by General Electric Medical Systems Information Techn — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2000
Date Received
September 22, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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  • 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)
  • 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)

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