Unipro (K-UNIPRO-US)
K-Number: K232441 · 2024-08-30
ApplicantTenscare, Ltd.
Decision Date2024-08-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Unipro (K-UNIPRO-US) is a medical device manufactured by Tenscare, Ltd.. It received FDA 510(k) clearance on 2024-08-30 under approval number K232441. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Unipro (K-UNIPRO-US)?
Unipro (K-UNIPRO-US) is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Tenscare, Ltd.. The 510(k) number is K232441.
When was Unipro (K-UNIPRO-US) approved by the FDA?
Unipro (K-UNIPRO-US) received FDA 510(k) clearance on 2024-08-30, under approval number K232441.
What company makes Unipro (K-UNIPRO-US)?
Unipro (K-UNIPRO-US) is manufactured by Tenscare, Ltd..
What is the FDA product code for Unipro (K-UNIPRO-US)?
The FDA product code for Unipro (K-UNIPRO-US) is GZJ.
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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.