DeviceClearance

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175— 510(k) K963227

Substantially Equivalent

Products For Medicine

FDA 510(k) clearance K963227 for WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175, Substantially Equivalent on 1996-10-23. Applicant: Products For Medicine.

Clearance details

Applicant
Products For Medicine
Product code
Code GCT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
La Quinta, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GCT

product code GCT
Malfunction
1,393
Other
2
Total
1,395

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.