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FDA 510(k)

FORE-SIGHT, MC-2000 SERIES

K-Number: K073036 · 2008-02-25

ApplicantCas Medical Systems, Inc.
Decision Date2008-02-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORE-SIGHT, MC-2000 SERIES 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 2008-02-25 under 510(k) number K073036. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORE-SIGHT, MC-2000 SERIES?

FORE-SIGHT, MC-2000 SERIES is a medical device that received FDA 510(k) clearance on 2008-02-25. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K073036.

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

FORE-SIGHT, MC-2000 SERIES received FDA 510(k) clearance on 2008-02-25, under 510(k) number K073036.

Who is the listed applicant for FORE-SIGHT, MC-2000 SERIES?

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, MC-2000 SERIES?

The FDA product code for FORE-SIGHT, MC-2000 SERIES is DQA.

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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: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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