M300 MONITOR/CONTROLLER T500 TREADMILL— 510(k) K873774

Name: FDA 510(k) clearance K873774
Creator: U.S. Food and Drug Administration
Published: 1987-11-06

Substantially Equivalent

Burdick Corp.

FDA 510(k) clearance K873774 for M300 MONITOR/CONTROLLER T500 TREADMILL, Substantially Equivalent on 1987-11-06. Applicant: Burdick Corp.. Device class: 2.

Clearance details

Applicant: Burdick Corp.
Product code: Code DXJ
Device class: Class 2
Regulation: 21 CFR 870.2450
Advisory panel: Cardiovascular
Date received: 1987-09-16
Decision date: 1987-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miltoon, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.