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FDA 510(k)

FORE-SIGHT ELITE Module Tissue Oximeter

K-Number: K180003 · 2018-05-10

ApplicantCas Medical Systems, Inc.
Decision Date2018-05-10
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORE-SIGHT ELITE Module Tissue Oximeter is a medical device manufactured by Cas Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-05-10 under approval number K180003. 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 Module Tissue Oximeter?

FORE-SIGHT ELITE Module Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2018-05-10. It is manufactured by Cas Medical Systems, Inc.. The 510(k) number is K180003.

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

FORE-SIGHT ELITE Module Tissue Oximeter received FDA 510(k) clearance on 2018-05-10, under approval number K180003.

What company makes FORE-SIGHT ELITE Module Tissue Oximeter?

FORE-SIGHT ELITE Module Tissue Oximeter is manufactured by Cas Medical Systems, Inc..

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

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

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Other Devices by Cas Medical Systems, Inc.

K190270FORE-SIGHT ELITE Tissue Oximeter Module

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.

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