K110429

Substantially Equivalent

PROSIM 4, PROSIM 6, PROSIM 8

Applicant: Fluke Biomedical
Product code: DRT
Advisory panel: Cardiovascular
Date received: 2011-02-15
Decision date: 2011-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.