U-200 BAG— 510(k) K821854

Substantially Equivalent

Medical Technologies of Georgia

FDA 510(k) clearance K821854 for U-200 BAG, Substantially Equivalent on 1982-07-22. Applicant: Medical Technologies of Georgia.

Clearance details

Applicant
Medical Technologies of Georgia
Product code
Code KNX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

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.