EIGEN FLORO-STOR FS-100— 510(k) K844375

Substantially Equivalent

Eigen Video

FDA 510(k) clearance K844375 for EIGEN FLORO-STOR FS-100, Substantially Equivalent on 1985-03-26. Applicant: Eigen Video.

Clearance details

Applicant
Eigen Video
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nevada City, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JAA

product code JAA
Other
1
Total
1

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.