510(k) K992713— POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101

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: 1999-08-12
Decision date: 1999-11-10
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.