Navigo Workstation 2.3 (FPRMC00039)
K-Number: K250664 · 2025-08-07
ApplicantUC-CARE , Ltd.
Decision Date2025-08-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Navigo Workstation 2.3 (FPRMC00039) is a medical device manufactured by UC-CARE , Ltd.. It received FDA 510(k) clearance on 2025-08-07 under approval number K250664. 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 2.3 (FPRMC00039)?
Navigo Workstation 2.3 (FPRMC00039) is a medical device that received FDA 510(k) clearance on 2025-08-07. It is manufactured by UC-CARE , Ltd.. The 510(k) number is K250664.
When was Navigo Workstation 2.3 (FPRMC00039) approved by the FDA?
Navigo Workstation 2.3 (FPRMC00039) received FDA 510(k) clearance on 2025-08-07, under approval number K250664.
What company makes Navigo Workstation 2.3 (FPRMC00039)?
Navigo Workstation 2.3 (FPRMC00039) is manufactured by UC-CARE , Ltd..
What is the FDA product code for Navigo Workstation 2.3 (FPRMC00039)?
The FDA product code for Navigo Workstation 2.3 (FPRMC00039) is LLZ.
Other Devices by UC-CARE , Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.