K981733

Substantially Equivalent

DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111

Applicant: Medtronic Functional Diagnostics A/S
Product code: FFX
Advisory panel: Gastroenterology, Urology
Date received: 1998-05-18
Decision date: 1999-02-04
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.