FDA 510(k)

NaviSuite SSI Edition

K-Number: K163119 · 2017-05-01

Decision Date2017-05-01

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NaviSuite SSI Edition is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K163119. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviSuite SSI Edition?

NaviSuite SSI Edition is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Medcom GmbH. The 510(k) number is K163119.

When did NaviSuite SSI Edition receive FDA 510(k) clearance?

NaviSuite SSI Edition received FDA 510(k) clearance on 2017-05-01, under 510(k) number K163119.

Who is the listed applicant for NaviSuite SSI Edition?

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 NaviSuite SSI Edition?

The FDA product code for NaviSuite SSI Edition is LLZ.

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.

K181789VeriSuite K180308Prelude K170841BiopSee, Mobile US

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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.