EPS— 510(k) K974504

Substantially Equivalent

E For M Imaging Systems Div., Marquette Electronic

FDA 510(k) clearance K974504 for EPS, Substantially Equivalent on 1998-02-27. Applicant: E For M Imaging Systems Div., Marquette Electronic.

Clearance details

Applicant
E For M Imaging Systems Div., Marquette Electronic
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Torrance, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.