Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C

K-Number: K082327 · 2009-04-03

ApplicantSomanetics Corp.
Decision Date2009-04-03
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 2009-04-03 under 510(k) number K082327. 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 2009-04-03. The listed applicant is Somanetics Corp.. The 510(k) number is K082327.

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 2009-04-03, under 510(k) number K082327.

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.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-SK080769INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100CK051274INVOS SYSTEMK040162CORRESTORE PATCH SYSTEMK031586CORRESTORE PATCH SYSTEM

View all 12 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.

↑