CADWELL 7400— 510(k) K822214

Substantially Equivalent

Cadwell Laboratories, Inc.

FDA 510(k) clearance K822214 for CADWELL 7400, Substantially Equivalent on 1982-09-24. Applicant: Cadwell Laboratories, Inc..

Clearance details

Applicant
Cadwell Laboratories, Inc.
Product code
Code GWF
Advisory panel
Neurology
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 GWF

product code GWF
Malfunction
2,364
Other
4
Total
2,368

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.