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510(k) K243324

Masimo O3 Regional Oximeter by Masimo Corporation — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2025
Date Received
October 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation
Device Class
Class II
Regulation Number
870.2700
Review Panel
SU
Submission Type

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Other clearances for product code MUD

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  • K214072 — Masimo O3 Regional Oximeter System (May 6, 2022)
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