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FDA 510(k)

UC-CARE NaviGo Workstation

K-Number: K160934 · 2017-02-06

ApplicantUC-CARE , Ltd.
Decision Date2017-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UC-CARE NaviGo Workstation is the device name listed in this FDA 510(k) record. The listed applicant is UC-CARE , Ltd.. It received FDA 510(k) clearance on 2017-02-06 under 510(k) number K160934. 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 UC-CARE NaviGo Workstation?

UC-CARE NaviGo Workstation is a medical device that received FDA 510(k) clearance on 2017-02-06. The listed applicant is UC-CARE , Ltd.. The 510(k) number is K160934.

When did UC-CARE NaviGo Workstation receive FDA 510(k) clearance?

UC-CARE NaviGo Workstation received FDA 510(k) clearance on 2017-02-06, under 510(k) number K160934.

Who is the listed applicant for UC-CARE NaviGo Workstation?

The FDA 510(k) record lists UC-CARE , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UC-CARE NaviGo Workstation?

The FDA product code for UC-CARE NaviGo Workstation is LLZ.

Other records listing UC-CARE , Ltd. 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.

K260161SmartGuide Disposable Guides and GridsK250664Navigo Workstation 2.3 (FPRMC00039)K173054Navigo Workstation Version 2.0

Related Devices (Code: LLZ)

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.

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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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