DeviceClearance

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

Substantially Equivalent

Diversatek Healthcare

FDA 510(k) clearance K190208 for Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe, Substantially Equivalent on 2019-10-03. Applicant: Diversatek Healthcare. Device class: 2.

Clearance details

Applicant
Diversatek Healthcare
Product code
Code FFX
Device class
Class 2
Regulation
21 CFR 876.1725
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Highlands Ranch, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FFX

product code FFX
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K190208

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190208.

Data sourced from openFDA. This site is unofficial and independent of the FDA.