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510(k) K223651

Device
Cerebral Adaptive Index (CAI) Algorithm
Applicant
Edwards Lifesciences, LLC
510(k) number
K223651
Product code
MUD
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-26
Date received
2022-12-06
Regulation
870.2700
Classification name
Oximeter, Tissue Saturation
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sara Pesian
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MUD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254129Spectrum-2Neko Health AB2026-05-22
K243324Masimo O3 Regional OximeterMasimo Corporation2025-07-17
K250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.2025-06-26
K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences2024-10-16
K241393ODI-TechOdi Medical AS2024-08-30
K240601SnapshotNIR model KD205Kent Imaging, Inc.2024-04-02
K232385OxiplexTS200Iss Medical, Inc.2024-03-01
K233488Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc.2024-02-28
K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC2023-11-17
K214072Masimo O3 Regional Oximeter SystemMasimo Corporation2022-05-06
K221010Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc.2022-05-03
K211561INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)Covidien, LLC2021-12-05
K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC2021-02-10
K201976SnapshotNIRKent Imaging2020-11-10
K201432Masimo O3 Regional Oximeter SystemMasimo Corporation2020-08-29