ELECTRO FLO PERCUSSOR, MODEL 5000— 510(k) K031876

Name: FDA 510(k) clearance K031876
Creator: U.S. Food and Drug Administration
Published: 2003-11-21

Substantially Equivalent

Med Systems

FDA 510(k) clearance K031876 for ELECTRO FLO PERCUSSOR, MODEL 5000, Substantially Equivalent on 2003-11-21. Applicant: Med Systems. Device class: 2.

Clearance details

Applicant: Med Systems
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Date received: 2003-06-17
Decision date: 2003-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.