FDA 510(k)

VeriSuite

K-Number: K181789 · 2018-09-21

Decision Date2018-09-21

Product CodeLHN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VeriSuite is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K181789. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VeriSuite?

VeriSuite is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Medcom GmbH. The 510(k) number is K181789.

When did VeriSuite receive FDA 510(k) clearance?

VeriSuite received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181789.

Who is the listed applicant for VeriSuite?

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

What is the FDA product code for VeriSuite?

The FDA product code for VeriSuite is LHN.

Other records listing Medcom GmbH 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.

K180308Prelude K170841BiopSee, Mobile US K163119NaviSuite SSI Edition

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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.