ECHO CARDIOGRAM PAD— 510(k) K791189

Name: FDA 510(k) clearance K791189
Creator: U.S. Food and Drug Administration
Published: 1979-07-17

Substantially Equivalent

Alimed, Inc.

FDA 510(k) clearance K791189 for ECHO CARDIOGRAM PAD, Substantially Equivalent on 1979-07-17. Applicant: Alimed, Inc.. Device class: 1.

Clearance details

Applicant: Alimed, Inc.
Product code: Code FNJ
Device class: Class 1
Regulation: 21 CFR 880.5120
Advisory panel: General Hospital
Date received: 1979-06-26
Decision date: 1979-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.