PROSIM 4, PROSIM 6, PROSIM 8— 510(k) K110429

Name: FDA 510(k) clearance K110429
Creator: U.S. Food and Drug Administration
Published: 2011-09-02

Substantially Equivalent

Fluke Biomedical

FDA 510(k) clearance K110429 for PROSIM 4, PROSIM 6, PROSIM 8, Substantially Equivalent on 2011-09-02. Applicant: Fluke Biomedical. Device class: 2.

Clearance details

Applicant: Fluke Biomedical
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2011-02-15
Decision date: 2011-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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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.