MPS450 MULTIPARAMETER SIMULATOR— 510(k) K103336

Substantially Equivalent

Fluke Biomedical

FDA 510(k) clearance K103336 for MPS450 MULTIPARAMETER SIMULATOR, Substantially Equivalent on 2011-04-13. Applicant: Fluke Biomedical.

Clearance details

Applicant: Fluke Biomedical
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2010-11-15
Decision date: 2011-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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.