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FDA 510(k)

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C

K-Number: K080769 · 2008-05-14

ApplicantSomanetics Corp.
Decision Date2008-05-14
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C is the device name listed in this FDA 510(k) record. The listed applicant is Somanetics Corp.. It received FDA 510(k) clearance on 2008-05-14 under 510(k) number K080769. 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 INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C?

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C is a medical device that received FDA 510(k) clearance on 2008-05-14. The listed applicant is Somanetics Corp.. The 510(k) number is K080769.

When did INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C receive FDA 510(k) clearance?

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C received FDA 510(k) clearance on 2008-05-14, under 510(k) number K080769.

Who is the listed applicant for INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C?

The FDA 510(k) record lists Somanetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C?

The FDA product code for INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C is MUD.

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Other records listing Somanetics Corp. 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.

K093422VITAL SYNC MODEL 5000 SERIESK091224OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-SK082327INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100CK051274INVOS SYSTEMK040162CORRESTORE PATCH SYSTEMK031586CORRESTORE PATCH SYSTEM

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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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