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510(k) K223651

Cerebral Adaptive Index (CAI) Algorithm by Edwards Lifesciences, LLC — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2023
Date Received
December 6, 2022
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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  • K241393 — ODI-Tech (August 30, 2024)
  • K240601 — SnapshotNIR model KD205 (April 2, 2024)
  • K232385 — OxiplexTS200 (March 1, 2024)
  • K233488 — Intra.Ox™ 2.0 Handheld Tissue Oximeter (February 28, 2024)
  • K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin (November 17, 2023)
  • K214072 — Masimo O3 Regional Oximeter System (May 6, 2022)
  • K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter (May 3, 2022)