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510(k) K182429

Masimo O3 Regional Oximeter System by Masimo Corporation — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2019
Date Received
September 6, 2018
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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  • K223651 — Cerebral Adaptive Index (CAI) Algorithm (May 26, 2023)
  • K214072 — Masimo O3 Regional Oximeter System (May 6, 2022)