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510(k) K232389

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue by Masimo Corporation — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2023
Date Received
August 9, 2023
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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  • K232512 — Masimo W1 (November 17, 2023)
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  • K223498 — Radius VSM and Accessories (June 1, 2023)

Other clearances for product code DQA

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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)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)