OMNI II PATIENT MONITOR— 510(k) K103737

Substantially Equivalent

Infinium Medical

FDA 510(k) clearance K103737 for OMNI II PATIENT MONITOR, Substantially Equivalent on 2011-06-02. Applicant: Infinium Medical.

Clearance details

Applicant: Infinium Medical
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2010-12-22
Decision date: 2011-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.