INVOS SYSTEM— 510(k) K051274

Substantially Equivalent

Somanetics Corp.

FDA 510(k) clearance K051274 for INVOS SYSTEM, Substantially Equivalent on 2005-11-04. Applicant: Somanetics Corp..

Clearance details

Applicant: Somanetics Corp.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2005-05-17
Decision date: 2005-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

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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.