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FDA 510(k)

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

K-Number: K190208 · 2019-10-03

ApplicantDiversatek Healthcare
Decision Date2019-10-03
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is a medical device manufactured by Diversatek Healthcare. It received FDA 510(k) clearance on 2019-10-03 under approval number K190208. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe?

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Diversatek Healthcare. The 510(k) number is K190208.

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

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe received FDA 510(k) clearance on 2019-10-03, under approval number K190208.

What company makes Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe?

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is manufactured by Diversatek Healthcare.

What is the FDA product code for Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe?

The FDA product code for Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is FFX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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