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FDA 510(k)

FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)

K-Number: K091452 · 2009-08-21

ApplicantCas Medical Systems, Inc.
Decision Date2009-08-21
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) 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 2009-08-21 under 510(k) number K091452. 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, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)?

FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) is a medical device that received FDA 510(k) clearance on 2009-08-21. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K091452.

When did FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) receive FDA 510(k) clearance?

FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) received FDA 510(k) clearance on 2009-08-21, under 510(k) number K091452.

Who is the listed applicant for FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)?

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, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)?

The FDA product code for FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) 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 SELECTK123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERK112820FORE-SIGHT ABSOLUTE TISSUE OXIMETERK094030FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030

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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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