OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S— 510(k) K091224

Name: FDA 510(k) clearance K091224
Creator: U.S. Food and Drug Administration
Published: 2009-07-09

Substantially Equivalent

Somanetics Corp.

FDA 510(k) clearance K091224 for OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S, Substantially Equivalent on 2009-07-09. 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: 2009-04-27
Decision date: 2009-07-09
Decision: Substantially Equivalent
Clearance type: Special
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.