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FDA 510(k)

NaviSuite SSI Edition

K-Number: K163119 · 2017-05-01

ApplicantMedcom GmbH
Decision Date2017-05-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NaviSuite SSI Edition is a medical device manufactured by Medcom GmbH. It received FDA 510(k) clearance on 2017-05-01 under approval 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. It is manufactured by Medcom GmbH. The 510(k) number is K163119.

When was NaviSuite SSI Edition approved by the FDA?

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

What company makes NaviSuite SSI Edition?

NaviSuite SSI Edition is manufactured by Medcom GmbH.

What is the FDA product code for NaviSuite SSI Edition?

The FDA product code for NaviSuite SSI Edition is LLZ.

Other Devices by Medcom GmbH

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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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