FLOORSTAND, FIBER OPTIC LIGHT SOURCE— 510(k) K760176

Substantially Equivalent

V. Mueller O.V. Baxter Healthcare Corp.

FDA 510(k) clearance K760176 for FLOORSTAND, FIBER OPTIC LIGHT SOURCE, Substantially Equivalent on 1976-08-30. Applicant: V. Mueller O.V. Baxter Healthcare Corp..

Clearance details

Applicant
V. Mueller O.V. Baxter Healthcare Corp.
Product code
Code FCW
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 FCW

product code FCW
Malfunction
912
Other
1
Total
913

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.