510(k) K190208— Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

Substantially Equivalent

Diversatek Healthcare

Clearance details

Applicant: Diversatek Healthcare
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-04
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highlands Ranch, CO, US

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.