K200976

Substantially Equivalent

SR-8230, SR-8230S Portable X-ray Unit

Applicant
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Product code
IZL
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shantou, CN
Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL
Other
3
Total
3

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.