510(k) K011471— BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

Substantially Equivalent

Medtronic Functional Diagnostics A/S

Clearance details

Applicant: Medtronic Functional Diagnostics A/S
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2001-05-14
Decision date: 2002-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skovlunde, DK

Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.