MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE— 510(k) K902005

Substantially Equivalent

Omega Medical Imaging, Inc.

FDA 510(k) clearance K902005 for MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE, Substantially Equivalent on 1990-09-20. Applicant: Omega Medical Imaging, Inc..

Clearance details

Applicant
Omega Medical Imaging, Inc.
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sanford, FL, 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.