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510(k) K091787

MODEL 6000 TWO PARAMETER BEDSIDE MONITOR by Ivy Biomedical Systems, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2009
Date Received
June 17, 2009
Clearance Type
Traditional
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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  • K171778 — MR Wireless Gating System, Model WGS-100 (March 14, 2018)
  • K170828 — Cardiac Trigger Monitor (May 17, 2017)
  • K151781 — Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (May 27, 2016)
  • K110987 — CARDIAC TRIGGER MONITOR (July 22, 2011)
  • K091985 — UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE (July 24, 2009)
  • K083854 — CARDIAC TRIGGER, MODEL: CTM300 (February 13, 2009)

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  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)