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510(k) K230612

Edwards Algorithm for Measurement of Blood Hemoglobin by Edwards Lifesciences, LLC — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2023
Date Received
March 6, 2023
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

Other clearances by Edwards Lifesciences, LLC

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  • K253034 — HemoSphere Stream Module (October 21, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K252364 — Edwards eSheath Optima introducer set (August 29, 2025)
  • K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); Hem (July 23, 2025)
  • K242518 — Hypertension Prediction Index (HePI) Algorithm (May 15, 2025)
  • K244046 — Edwards eSheath Optima introducer set (March 27, 2025)
  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)

Other clearances for product code MUD

  • K243324 — Masimo O3 Regional Oximeter (July 17, 2025)
  • K250519 — Lap.Ox™ Laparoscopic Tissue Oximeter (June 26, 2025)
  • K240596 — Cerebral Autoregulation Index (CAI) Algorithm (October 16, 2024)
  • 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)
  • K223651 — Cerebral Adaptive Index (CAI) Algorithm (May 26, 2023)
  • K214072 — Masimo O3 Regional Oximeter System (May 6, 2022)
  • K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter (May 3, 2022)