Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FORE-SIGHT ELITE Absolute Tissue Oximeter

K-Number: K203490 · 2021-02-10

ApplicantEdwards Lifesciences, LLC
Decision Date2021-02-10
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORE-SIGHT ELITE Absolute Tissue Oximeter is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2021-02-10 under approval number K203490. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORE-SIGHT ELITE Absolute Tissue Oximeter?

FORE-SIGHT ELITE Absolute Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2021-02-10. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K203490.

When was FORE-SIGHT ELITE Absolute Tissue Oximeter approved by the FDA?

FORE-SIGHT ELITE Absolute Tissue Oximeter received FDA 510(k) clearance on 2021-02-10, under approval number K203490.

What company makes FORE-SIGHT ELITE Absolute Tissue Oximeter?

FORE-SIGHT ELITE Absolute Tissue Oximeter is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for FORE-SIGHT ELITE Absolute Tissue Oximeter?

The FDA product code for FORE-SIGHT ELITE Absolute Tissue Oximeter is MUD.

Related Clinical Trials

NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING NCT06911385 Augmenting Cerebral Blood Flow in Acute Ischemic Stroke NOT_YET_RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by Edwards Lifesciences, LLC

K161962VAMP Venous/Arterial Blood Management Protection System K160645PreSep Oligon Oximetry Catheter K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160084Swan Ganz Catheters K152980Flo Trac sensor, Volume View sensor K172660Duravess bovine pericardial vascular patch

View all 64 devices →

Related Devices (Code: MUD)

K153426Ox-Imager CSModulated Imaging, Inc. K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc. K162117NIRO-200NX DPHamamatsu Photonics K.K. K160526Masimo O3 Regional Oximeter SystemMasimo Corporation K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. K162603Masimo O3 Regional Oximeter SystemMasimo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑