NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA— 510(k) K844578

Name: FDA 510(k) clearance K844578
Creator: U.S. Food and Drug Administration
Published: 1985-05-14

Substantially Equivalent

Engineering Dynamics Corp.

FDA 510(k) clearance K844578 for NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA, Substantially Equivalent on 1985-05-14. Applicant: Engineering Dynamics Corp.. Device class: 2.

Clearance details

Applicant: Engineering Dynamics Corp.
Product code: Code FPO
Device class: Class 2
Regulation: 21 CFR 880.6910
Advisory panel: General Hospital
Date received: 1984-11-23
Decision date: 1985-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lowell, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPO

product code FPO

Death: 29
Injury: 254
Malfunction: 5,054
Other: 10
Total: 5,347

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.