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FDA 510(k)

Navigo Workstation Version 2.0

K-Number: K173054 · 2018-01-16

ApplicantUC-CARE , Ltd.
Decision Date2018-01-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Navigo Workstation Version 2.0 is a medical device manufactured by UC-CARE , Ltd.. It received FDA 510(k) clearance on 2018-01-16 under approval number K173054. 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 Navigo Workstation Version 2.0?

Navigo Workstation Version 2.0 is a medical device that received FDA 510(k) clearance on 2018-01-16. It is manufactured by UC-CARE , Ltd.. The 510(k) number is K173054.

When was Navigo Workstation Version 2.0 approved by the FDA?

Navigo Workstation Version 2.0 received FDA 510(k) clearance on 2018-01-16, under approval number K173054.

What company makes Navigo Workstation Version 2.0?

Navigo Workstation Version 2.0 is manufactured by UC-CARE , Ltd..

What is the FDA product code for Navigo Workstation Version 2.0?

The FDA product code for Navigo Workstation Version 2.0 is LLZ.

Other Devices by UC-CARE , Ltd.

K160934UC-CARE NaviGo Workstation K250664Navigo Workstation 2.3 (FPRMC00039)

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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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