OMBRA TABLE TOP COMPRESSOR— 510(k) K131881

Substantially Equivalent

Trudell Medical Intl.

FDA 510(k) clearance K131881 for OMBRA TABLE TOP COMPRESSOR, Substantially Equivalent on 2013-10-24. Applicant: Trudell Medical Intl..

Clearance details

Applicant: Trudell Medical Intl.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 2013-06-25
Decision date: 2013-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.