EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG— 510(k) K920867

Substantially Equivalent

Electro Medical Equipment Co., Inc.

FDA 510(k) clearance K920867 for EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG, Substantially Equivalent on 1992-04-10. Applicant: Electro Medical Equipment Co., Inc..

Clearance details

Applicant: Electro Medical Equipment Co., Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1992-02-25
Decision date: 1992-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baton Rouge, LA, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.