Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

FDA 510(k) K190208 · Diversatek Healthcare

Substantially Equivalent

510(k) numberK190208

Submission

Device name
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Applicant
Diversatek Healthcare
Highlands Ranch, CO, US
Received
February 4, 2019
Decision date
October 3, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FFX – System, Gastrointestinal Motility (Electrical)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1725
Specialty
Gastroenterology, Urology

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Questions and answers

When was Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe cleared by the FDA?

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) received a 510(k) decision of Substantially Equivalent on October 3, 2019, 241 days after the submission was received.

What is the product code of K190208?

The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.