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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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2021-02-10 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K203490.

When did FORE-SIGHT ELITE Absolute Tissue Oximeter receive FDA 510(k) clearance?

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

Who is the listed applicant for FORE-SIGHT ELITE Absolute Tissue Oximeter?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing Edwards Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MUD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254129Spectrum-2Neko Health ABK243324Masimo O3 Regional OximeterMasimo CorporationK250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards LifesciencesK241393ODI-TechOdi Medical ASK240601SnapshotNIR model KD205Kent Imaging, Inc.

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.

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