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FDA 510(k)

FORE-SIGHT ELITE Tissue Oximeter Module

K-Number: K190270 · 2019-10-21

ApplicantCas Medical Systems, Inc.
Decision Date2019-10-21
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORE-SIGHT ELITE Tissue Oximeter Module is the device name listed in this FDA 510(k) record. The listed applicant is Cas Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-10-21 under 510(k) number K190270. 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 Tissue Oximeter Module?

FORE-SIGHT ELITE Tissue Oximeter Module is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K190270.

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

FORE-SIGHT ELITE Tissue Oximeter Module received FDA 510(k) clearance on 2019-10-21, under 510(k) number K190270.

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

The FDA 510(k) record lists Cas Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cas Medical Systems, Inc. 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.

K180003FORE-SIGHT ELITE Module Tissue Oximeter

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

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

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