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510(k) K221953

Masimo CARESCAPE SpO2 – Masimo with SpHb by Masimo Corporation — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2022
Date Received
July 5, 2022
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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  • 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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