INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C— 510(k) K080769

Name: FDA 510(k) clearance K080769
Creator: U.S. Food and Drug Administration
Published: 2008-05-14

Substantially Equivalent

Somanetics Corp.

FDA 510(k) clearance K080769 for INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C, Substantially Equivalent on 2008-05-14. Applicant: Somanetics Corp.. Device class: 2.

Clearance details

Applicant: Somanetics Corp.
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2008-03-18
Decision date: 2008-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.