MONTERIS MEDICAL UFO— 510(k) K090240

Substantially Equivalent

Monteris Medical,

FDA 510(k) clearance K090240 for MONTERIS MEDICAL UFO, Substantially Equivalent on 2009-08-06. Applicant: Monteris Medical,.

Clearance details

Applicant: Monteris Medical,
Product code: Code HAW
Advisory panel: Neurology
Date received: 2009-02-02
Decision date: 2009-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.