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510(k) K982255

MODEL 2000 PULSE OXIMETER by Ivy Biomedical Systems, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1998
Date Received
June 26, 1998
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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  • K091787 — MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (October 9, 2009)
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  • 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)
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