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FDA 510(k)

FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER

K-Number: K123700 · 2013-04-11

ApplicantCas Medical Systems, Inc.
Decision Date2013-04-11
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 Cas Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-04-11 under 510(k) number K123700. 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 2013-04-11. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K123700.

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 2013-04-11, under 510(k) number K123700.

Who is the listed applicant for FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER?

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 ABSOLUTE TISSUE OXIMETER?

The FDA product code for FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER is MUD.

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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.

K190270FORE-SIGHT ELITE Tissue Oximeter ModuleK180003FORE-SIGHT ELITE Module Tissue OximeterK130411740 SELECTK112820FORE-SIGHT ABSOLUTE TISSUE OXIMETERK094030FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030K091452FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)

View all 28 devices →

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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