K082327

Substantially Equivalent

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C

Applicant: Somanetics Corp.
Product code: MUD
Advisory panel: Cardiovascular
Date received: 2008-08-14
Decision date: 2009-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

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.