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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 the device name listed in this FDA 510(k) record. The listed applicant is Diversatek Healthcare. It received FDA 510(k) clearance on 2019-10-03 under 510(k) 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. The listed applicant is Diversatek Healthcare. The 510(k) number is K190208.

When did Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe receive FDA 510(k) clearance?

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

Who is the listed applicant for Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe?

The FDA 510(k) record lists Diversatek Healthcare as the applicant. This does not by itself establish the device manufacturer.

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

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

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