FDA 510(k)

THD Procto Software System

K-Number: K193512 · 2020-01-26

Decision Date2020-01-26

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

THD Procto Software System is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2020-01-26 under 510(k) number K193512. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THD Procto Software System?

THD Procto Software System is a medical device that received FDA 510(k) clearance on 2020-01-26. The listed applicant is Thd Spa. The 510(k) number is K193512.

When did THD Procto Software System receive FDA 510(k) clearance?

THD Procto Software System received FDA 510(k) clearance on 2020-01-26, under 510(k) number K193512.

Who is the listed applicant for THD Procto Software System?

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

What is the FDA product code for THD Procto Software System?

The FDA product code for THD Procto Software System is IYO.

Other records listing Thd Spa as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211623THD Procto Software System K180135THD Anopress with THD SensyProbe K161785THD ANOPRESS

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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.