VASCUVIEW ULTRASOUND SYSTEM— 510(k) K080049

Substantially Equivalent

Escalon Medical Corp.

FDA 510(k) clearance K080049 for VASCUVIEW ULTRASOUND SYSTEM, Substantially Equivalent on 2008-01-23. Applicant: Escalon Medical Corp..

Clearance details

Applicant
Escalon Medical Corp.
Product code
Code IYO
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Berlin, WI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code IYO

product code IYO
Malfunction
3,339
Total
3,339

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.