BINGO PRO— 510(k) K111474

Substantially Equivalent

Forum Engineering Technologies (96) , Ltd.

FDA 510(k) clearance K111474 for BINGO PRO, Substantially Equivalent on 2011-11-02. Applicant: Forum Engineering Technologies (96) , Ltd..

Clearance details

Applicant
Forum Engineering Technologies (96) , Ltd.
Product code
Code LQY
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rishon Lezion, IL
Download summary PDFView on FDA.gov ↗

Adverse events under product code LQY

product code LQY
Malfunction
504
Total
504

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.