ANORECTAL MANOMETRY SUITE, MODEL 9032S0201— 510(k) K991389

Substantially Equivalent

Medtronic Functional Diagnostics A/S

FDA 510(k) clearance K991389 for ANORECTAL MANOMETRY SUITE, MODEL 9032S0201, Substantially Equivalent on 1999-07-15. Applicant: Medtronic Functional Diagnostics A/S.

Clearance details

Applicant: Medtronic Functional Diagnostics A/S
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-21
Decision date: 1999-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

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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.